Current through September 30, 2024
Section 874.4750 - Laryngostroboscope(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