MODEL FS1
Device Facts
| Record ID | K790481 |
|---|---|
| Device Name | MODEL FS1 |
| Applicant | Starkey Laboratories, Inc. |
| Product Code | KHL · Ear, Nose, Throat |
| Decision Date | Apr 3, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.
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.
