OTOMETER PORTABLE SCREENING AUDIOMETER
Device Facts
| Record ID | K883169 |
|---|---|
| Device Name | OTOMETER PORTABLE SCREENING AUDIOMETER |
| Applicant | Otometer, Inc. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Dec 7, 1988 |
| 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.
