THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
Device Facts
| Record ID | K900197 |
|---|---|
| Device Name | THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER |
| Applicant | Sound Linked Data, Inc. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | Apr 17, 1991 |
| 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.
