K792214 is an FDA 510(k) clearance for the MODEL TM2-BEHIND-THE-EAR TINNITUS. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979, 25 days after receiving the submission on November 2, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K792214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1979 |
| Decision Date | November 27, 1979 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | BWF - Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |