K802560 is an FDA 510(k) clearance for the TINNITUS RESEARCH AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 27 days after receiving the submission on October 16, 1980.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K802560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | EWO - Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |