The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Tinnitus Research Audiometer.
| Device ID | K802560 |
| 510k Number | K802560 |
| Device Name: | TINNITUS RESEARCH AUDIOMETER |
| Classification | Audiometer |
| Applicant | STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-16 |
| Decision Date | 1980-11-12 |