The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Model Se-1 Eyeglass Hearing Aid.
| Device ID | K791203 |
| 510k Number | K791203 |
| Device Name: | MODEL SE-1 EYEGLASS HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | STARKEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-28 |
| Decision Date | 1979-08-10 |