part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "G"
subpart_subject: "General Hospital and Personal Use Miscellaneous Devices"
section_number: "880.6320"
section_subject: "AC-powered medical examination light."
cfr_reference: "21 CFR 880.6320"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.