DIGITAL AUDIOMETER/HEARING AID 3100
Device Facts
| Record ID | K833883 |
|---|---|
| Device Name | DIGITAL AUDIOMETER/HEARING AID 3100 |
| Applicant | Frye Electronics, Inc. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Feb 21, 1984 |
| 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.
