The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Starkey Tm-3, Tm-5 High Frequency Tinnitus Masker.
| Device ID | K964216 |
| 510k Number | K964216 |
| Device Name: | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER |
| Classification | Masker, Tinnitus |
| Applicant | STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH Eden Prairie, MN 55344 |
| Contact | Shari L Swiden |
| Correspondent | Shari L Swiden STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH Eden Prairie, MN 55344 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1996-12-06 |
| Summary: | summary |