AUDITORY LOCALIZER
Device Facts
| Record ID | K811772 |
|---|---|
| Device Name | AUDITORY LOCALIZER |
| Applicant | Western Advanced Technology, Inc. |
| Product Code | ETS · Ear, Nose, Throat |
| Decision Date | Jul 15, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
