EQL · Laryngostroboscope
Ear, Nose, Throat · 21 CFR 874.4750 · Class 1
Overview
| Product Code | EQL |
|---|---|
| Device Name | Laryngostroboscope |
| Regulation | 21 CFR 874.4750 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984521 | RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | Mar 17, 1999 | SESE |
| K921285 | 9105 RIGID TELESCOPIC ENDOSCOPE | Kay Elemetrics Corp. | May 28, 1992 | SESE |
| K921184 | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE | Kay Elemetrics Corp. | May 28, 1992 | SESE |
| K884933 | ENDOSTROBOSCOPE IV | Jedmed Instrument Co. | Feb 15, 1989 | SESE |
| K842090 | RHINO-LARYNX STROBOSCOPE TYPE 4914 | Bruel & Kjaer Industri A/S | Jul 18, 1984 | SESE |
| K822523 | LARYNGOSTROBOSCOPE | Kelleher Corp. | Sep 9, 1982 | SESE |
| K801866 | PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A | Pentax Precision Instrument Corp. | Sep 16, 1980 | SESE |
| K770466 | STOCKINGS, RVS TM | Parke-Davis Co. | Mar 28, 1977 | SESE |
Top Applicants
- Kay Elemetrics Corp. — 2 clearances
- Richard Wolf Medical Instruments Corp. — 1 clearance
- Pentax Precision Instrument Corp. — 1 clearance
- Parke-Davis Co. — 1 clearance
- Kelleher Corp. — 1 clearance
