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(b) Classification. Class II (performance standards).

(b) Classification. Class II (performance standards).

8868.1430 Carbon monoxide gas ana.

lyzer. (a) Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

(b) Classification. Class II (performance standards).

8868.1670 Neon gas analyzer.

(a) Identification. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.

(b) Classification. Class II (performance standards).

8 868.1500 Enflurane gas analyzer.

(a) Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

(b) Classification. Class II (performance standards).

$ 868.1690 Nitrogen gas analyzer.

(a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

(b) Classification. Class II (performance standards).

8868.1575 Gas collection vessel.

(a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8 868.9. (47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001)

$868.1700 Nitrous oxide gas analyzer.

(a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

(b) Classification. Class II (performance standards).

$ 868.1620 Halothane gas analyzer.

(a) Identification. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.

(b) Classification. Class II (performance standards).

$868.1720 Oxygen gas analyzer.

(a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

(b) Classification. Class II (performance standards).

$ 868.1640 Helium gas analyzer.

(a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques

iques such as thermal conductivity, gas chromatography, or mass spectrometry.

$ 868.1730 Oxygen uptake computer.

(a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

(b) Classification. Class II (performance standards).

8868.1750 Pressure plethysmograph. (b) Classification. Class II (perform(a) Identification. A

ance standards).

pressure plethysmograph is a device used to de

$ 868.1860 Peak-flow meter for termine a patient's airway resistance

spirometry. and lung volumes by measuring pres

(a) Identification. A peak-flow meter sure changes while the patient is in an

for spirometry is a device used to airtight box.

measure a patient's maximum venti(b) Classification. Class II (perform

latory flow rate. ance standards).

(b) Classification. Class II (perform$868.1760 Volume plethysmograph.

ance standards). (a) Identification. A volume $868.1870 Gas volume calibrator. plethysmograph is an airtight box, in

(a) Identification. A gas volume caliwhich a patient sits, that is used to de

brator is a device that is intended for termine the patient's lung volume

medical purposes and that is used to changes.

calibrate the output of gas volume (b) Classification. Class II (perform

measurement instruments by delivance standards).

ering a known gas volume. $868.1780 Inspiratory airway pressure

(b) Classification. Class I (general conmeter.

trols). The device is exempt from the

premarket notification procedures in (a) Identification. An inspiratory air

subpart E of part 807 of this chapter way pressure meter is a device used to

subject to the limitations in $868.9. measure the amount of pressure produced in a patient's airway during

[47 FR 31142, July 16, 1982, as amended at 61 maximal inspiration.

FR 1119, Jan. 16, 1996; 66 FR 38793, July 25,

2001] (b) Classification. Class II (performance standards).

8 868.1880 Pulmonary-function data

calculator. $868.1800 Rhinoanemometer.

(a) Identification. A pulmonary-func(a) Identification. A rhinoanemometer

tion data calculator is a device used to is a device used to quantify the amount

calculate pulmonary-function values of nasal congestion by measuring the

based on actual physical data obtained airflow through, and differential pres

during pulmonary-function testing. sure across, a patient's nasal passages.

(b) Classification. Class II (perform(b) Classification. Class II (perform

ance standards). ance standards).

8868.1890 Predictive pulmonary-func$868.1840 Diagnostic spirometer.

tion value calculator. (a) Identification. A diagnostic spi- (a) Identification. A predictive pulrometer is a device used in pulmonary monary-function value calculator is a function testing to measure the volume device used to calculate normal pulof gas moving in or out of a patient's monary-function values based on emlungs.

pirical equations. (b) Classification. Class II (perform

(b) Classification. Class II (performance standards).

ance standards). $868.1850 Monitoring spirometer. 8868.1900 Diagnostic pulmonary-func(a) Identification. A monitoring spi

tion interpretation calculator. rometer is a device used to measure (a) Identification. A diagnostic pulcontinuously a patient's tidal volume monary-function interpretation calcu(volume of gas inhaled by the patient lator is a device that interprets pulduring each respiration cycle) or monary study data to determine clinminute volume (the tidal volume mul- ical significance of pulmonary-function tiplied by the rate of respiration for 1 values. minute) for the evaluation of the pa- (b) Classification. Class II (performtient's ventilatory status.

ance standards).

good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001]

$ 868.1910 Esophageal stethoscope.

(a) Identification. Anesophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] 8868.1920 Esophageal stethoscope

with electrical conductors. (a) Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.

(b) Classification. Class II (performance standards).

8 868.1975 Water vapor analyzer.

(a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8 868.9. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

8868.1930 Stethoscope head.

(a) Identification. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $868.9. (47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001]

Subpart C-Monitoring Devices 8868.2025 Ultrasonic air embolism

monitor. (a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.

(b) Classification. Class II (performance standards).

$ 868.1965 Switching valve (ploss).

(a) Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an ear piece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8 868.9. The device is also exempt from the current

$ 868.2300 Bourdon gauge flowmeter.

(a) Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $ 868.9. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

$868.2320 Uncompensated thorpe tube

flowmeter. (a) Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8868.9. (47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001)

tient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 8 868.2377.

(b) Classification. Class II (performance standards). [47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002)

$868.2340 Compensated thorpe tube

flowmeter. (a) Identification. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $ 868.9. (47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

$ 868.2377 Apnea monitor.

(a) Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.” [67 FR 46852, July 17, 2002]

$868.2350 Gas calibration flowmeter.

(a) Identification. A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8 868.9. (47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

$ 868.2380 Nitric oxide analyzer.

(a) Identification. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.

(b) Classification. Class II. The special control for this device is FDA's "Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer." [65 FR 14465, Mar. 3, 2000]

$868.2385 Nitrogen dioxide analyzer.

(a) Identification. The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide.

(b) Classification. Class II. The special control for this device is FDA's "Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric

$868.2375 Breathing frequency mon

itor. (a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a pa

Oxide Analyzer, and Nitrogen Dioxide 8868.2500 Cutaneous oxygen (PcO2) Analyzer."

monitor. [65 FR 11465, Mar. 3, 2000)

(a) Identification. A cutaneous oxygen

(PCO2) monitor is a noninvasive, heated $ 868.2450 Lung water monitor.

sensor (e.g., a Clark-type polargraphic (a) Identification. A lung water mon electrode) placed on the patient's skin itor is a device used to monitor the that is intended to monitor relative trend of fluid volume changes in a pa changes in the cutaneous oxygen tentient's lung by measuring changes in sion. thoracic electrical impedance (resist- (b) Classification. Class II (special ance to alternating current) by means controls). The special control for this of electrodes placed on the patient's device is FDA's “Class II Special Conchest.

trols Guidance Document: Cutaneous (b) Classification. Class III (premarket Carbon Dioxide (PCO2) and Oxygen approval).

(PCO2) Monitors; Guidance for Industry (c) Date PMA or notice of completion of and FDA.” See $868.1(e) for the availa PDP is required. A PMA or a notice of ability of this guidance document. completion of a PDP for a device is required to be filed with the Food and

[67 FR 76681, Dec. 13, 2002) Drug Administration on or before July

8868.2550 Pneumotachometer. 12, 2000, for any lung water monitor that was in commercial distribution (a)

Identification. before May 28, 1976, or that has, on or pneumotachometer is a device intended before July 12, 2000, been found to be for medical purposes that is used to desubstantially equivalent to a lung termine gas flow by measuring the water monitor that was in commercial pressure differential across a known redistribution before May 28, 1976. Any sistance. The device may use a set of other lung water monitor device shall

capillaries or a metal screen for the rehave an approved PMA or declared

sistive element. completed PDP in effect before being

(b) Classification. Class II (performplaced in commercial distribution.

ance standards). [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 65 FR 19834, Apr. 13, $ 868.2600 Airway pressure monitor. 2000]

(a) Identification. An airway pressure $868.2480 Cutaneous carbon dioxide

monitor is a device used to measure (PcCO2) monitor.

the pressure in a patient's upper air

way. The device may include a pressure (a) Identification. A cutaneous carbon

gauge and an alarm. dioxide (PcC02) monitor is a

(b) Classification. Class II (performnoninvasive heated sensor and a pH

ance standards). sensitive glass electrode placed on a patient's skin, which is intended to

$868.2610 Gas pressure gauge. monitor relative changes in a hemodynamically stable patient's cu

(a) Identification. A gas pressure taneous carbon dioxide tension as an gauge (e.g., bourdon tube pressure adjunct to arterial carbon dioxide ten gauge) is a device intended for medical sion measurement.

purposes that is used to measure gas (b) Classification. Class II (special pressure in a medical gas delivery syscontrols). The special control for this tem. device is FDA's "Class II Special Con- (b) Classification. Class I (general controls Guidance Document: Cutaneous trols). The device is exempt from the Carbon Dioxide (PCO2) and Oxygen premarket notification procedures in (Pc02) Monitors; Guidance for Industry subpart E of part 807 of this chapter and FDA.” See $ 868.1(e) for the avail subject to the limitations in $868.9. ability of this guidance document.

[47 FR 31142, July 16, 1982, as amended at 61 (54 FR 27160, June 28, 1989, as amended at 67 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, FR 76681, Dec. 13, 2002]

2001]

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