The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Starkey Model P1 Module.
| Device ID | K873031 |
| 510k Number | K873031 |
| Device Name: | STARKEY MODEL P1 MODULE |
| Classification | Face Plate Hearing Aid |
| Applicant | STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Contact | Azad J Baksh |
| Correspondent | Azad J Baksh STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Product Code | LRB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1988-02-08 |