The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Model Tm2-behind-the-ear Tinnitus.
| Device ID | K792214 |
| 510k Number | K792214 |
| Device Name: | MODEL TM2-BEHIND-THE-EAR TINNITUS |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-02 |
| Decision Date | 1979-11-27 |