BELTONE PERSONAL HEARING SCREENER
Device Facts
| Record ID | K943616 |
|---|---|
| Device Name | BELTONE PERSONAL HEARING SCREENER |
| Applicant | Beltone Electronics Corp. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Jul 12, 1995 |
| 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.
