The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Tinnitus Masker.
| Device ID | K781798 |
| 510k Number | K781798 |
| Device Name: | TINNITUS MASKER |
| Classification | Masker, Tinnitus |
| Applicant | STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-23 |
| Decision Date | 1978-11-03 |