101, 151, 161 PORTABLE AUDIOMETERS
Device Facts
| Record ID | K802963 |
|---|---|
| Device Name | 101, 151, 161 PORTABLE AUDIOMETERS |
| Applicant | Amplaid USA, Inc. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Dec 19, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
