21 CFR 880.6320 - AC-powered medical examination light.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart G [§ 880.6025 - § 880.6992]

§ 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.

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

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

cite as: 21 CFR 880.6320