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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1.3. rezultāts no 78.
445. lappuse
... powered device with a detector that is intended to measure , without touching the patient's skin , the self ... powered or an AC- powered liquid crystal thermographic sys- tem intended for adjunctive use in diag- nostic screening for ...
... powered device with a detector that is intended to measure , without touching the patient's skin , the self ... powered or an AC- powered liquid crystal thermographic sys- tem intended for adjunctive use in diag- nostic screening for ...
466. lappuse
... powered or battery - powered device containing illumination and viewing optics intended to examine the media ( cornea , aqueous , lens , and vit- reous ) and the retina of the eye . ( b ) Classification . Class II . § 886.1605 Perimeter ...
... powered or battery - powered device containing illumination and viewing optics intended to examine the media ( cornea , aqueous , lens , and vit- reous ) and the retina of the eye . ( b ) Classification . Class II . § 886.1605 Perimeter ...
469. lappuse
... powered device and the battery - powered device are exempt from the premarket notification proce- dures in subpart E of part 807 of this chapter , subject to the limitations in § 886.9 . The battery - powered device is also exempt from ...
... powered device and the battery - powered device are exempt from the premarket notification proce- dures in subpart E of part 807 of this chapter , subject to the limitations in § 886.9 . The battery - powered device is also exempt from ...
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