21 CFR 874.4750
§ 874.4750 Laryngostroboscope.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.4750, § 874.4750 Laryngostroboscope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90247
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Full text
(a) Identification. A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.
(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 § 874.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.