LARYNGOSTROBOSCOPE
Device Facts
| Record ID | K822523 |
|---|---|
| Device Name | LARYNGOSTROBOSCOPE |
| Applicant | Kelleher Corp. |
| Product Code | EQL · Ear, Nose, Throat |
| Decision Date | Sep 9, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4750 |
| Device Class | Class 1 |
Regulatory Classification
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.
