OTOVIEW ENDOSCOPY SYSTEM
Device Facts
| Record ID | K934432 |
|---|---|
| Device Name | OTOVIEW ENDOSCOPY SYSTEM |
| Applicant | Smith & Nephew Richards, Inc. |
| Product Code | EWA · Ear, Nose, Throat |
| Decision Date | Apr 25, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1080 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An audiometer calibration set is an electronic reference device that is intended to calibrate an audiometer. It measures the sound frequency and intensity characteristics that emanate from an audiometer earphone. The device consists of an acoustic cavity of known volume, a sound level meter, a microphone with calibration traceable to the National Bureau of Standards, oscillators, frequency counters, microphone amplifiers, and a recorder. The device can measure selected audiometer test frequencies at a given intensity level, and selectable audiometer attenuation settings at a given test frequency.
