21 CFR 874.4750 — Laryngostroboscope
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4750
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EQL | Laryngostroboscope | 1 | 8 |
