ORBITER 922 CLINICAL AUDIOMETER
Device Facts
| Record ID | K931324 |
|---|---|
| Device Name | ORBITER 922 CLINICAL AUDIOMETER |
| Applicant | Madsen Electronics (Canada) , Ltd. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Nov 19, 1993 |
| 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.
