K790846 is an FDA 510(k) clearance for the MIDDLE EAR ANALYZER (IMPED. AUDIOMTR). This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Grason-Stadler, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 17, 1979, 13 days after receiving the submission on May 4, 1979.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K790846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1979 |
| Decision Date | May 17, 1979 |
| Days to Decision | 13 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 |