Code of Federal Regulations 21 Parts 800 to 1299 Food and Drugs: Revised as of April 1 2006U.S. Government Printing Office, 2006 - 796 lappuses The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government. This volumwe contains the regulations about medical devices. |
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303. lappuse
... device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the pa- tient . ( b ) Classification . Class I ( general con- trols ) . The device is exempt from the premarket notification ...
... device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the pa- tient . ( b ) Classification . Class I ( general con- trols ) . The device is exempt from the premarket notification ...
465. lappuse
... instrument is an AC - powered device in- tended to measure the power of lenses , prisms , and their centers ( e.g. , lensometer ) . ( b ) Classification . Class I ( general con- trols ) . The device is exempt from the premarket ...
... instrument is an AC - powered device in- tended to measure the power of lenses , prisms , and their centers ( e.g. , lensometer ) . ( b ) Classification . Class I ( general con- trols ) . The device is exempt from the premarket ...
477. lappuse
... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter , subject to the limitations in § 886.9 . The device is also exempt from the current good manufacturing practice regula- tions in part ...
... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter , subject to the limitations in § 886.9 . The device is also exempt from the current good manufacturing practice regula- tions in part ...
Saturs
1 For nomenclature changes to chapter I see 59 FR 14366 Mar 28 1994 | 3 |
Labeling | 13 |
Medical device reporting | 38 |
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AC-powered accessories accreditation body amended at 65 ance standards application blood cardiopulmonary bypass catheter chapter subject Class II perform Class II special Classification clinical clude commercial distribution complaint files component current good manufacturing Date PMA dental denture device intended device is exempt device that consists disease electronic equipment facility FDA's fluoroscopic Food and Drug guidance document Identification image receptor immunological test system implanted intended for medical intended to measure July 25 labeling limitations mammography manufacturing practice manufacturing practice regula means medical purposes ment monitor notice of completion paragraph patient PDP is required plasma PMA or notice postmarket surveillance premarket approval premarket notification procedures procedures in subpart prosthesis radiation reagents regulation requirements concerning records respect to complaint Sept serological serum special controls specific submit subpart E surgical tion tissue trols type of device vice x-ray system