PHOENIX SYSTEM SEVEN.
Device Facts
| Record ID | K862592 |
|---|---|
| Device Name | PHOENIX SYSTEM SEVEN. |
| Applicant | Nicolet Biomedical Instruments |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Sep 16, 1986 |
| 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.
