21 C.F.R. § 874.4750 Laryngostroboscope.
Title 21 - Food and Drugs
(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. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001]
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart E—Surgical Devices
§ 874.4750 Laryngostroboscope.
