OTOACOUSTIC EMISSIONS UNIT CELESTA 503
Device Facts
| Record ID | K931325 |
|---|---|
| Device Name | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 |
| Applicant | Madsen Electronics (Canada) , Ltd. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Feb 18, 1994 |
| 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.
