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21 CFR 880.6320

§ 880.6320 AC-powered medical examination light.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 880.6320, § 880.6320 AC-powered medical examination light, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90588
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.