21 CFR 878.4700

§ 878.4700 Surgical microscope and accessories.

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

Cite this

Citation: 21 CFR 878.4700, § 878.4700 Surgical microscope and accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90452
Permanent ID: ys:prov:90452@1
SHA-256: 788c9e252dcb33c3bd75c718b14769925fe47e0396bbd93509e74c35040aa10c

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Full text

(a) Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. (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 § 878.9.

Legislative history

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