21 C.F.R. § 880.6320

Current through October 31, 2024
Section 880.6320 - AC-powered medical examination light
(a)Identification. An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
(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 § 880.9 .

21 C.F.R. §880.6320

45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38806 , July 25, 2001