K863353 is an FDA 510(k) clearance for the MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER). This device is classified as a Tester, Auditory Impedance (Class II - Special Controls, product code ETY).
Submitted by Grason-Stadler, Inc. (Littleton, US). The FDA issued a Cleared decision on November 3, 1986, 66 days after receiving the submission on August 29, 1986.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1090.
| 510(k) Number | K863353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1986 |
| Decision Date | November 03, 1986 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ETY — Tester, Auditory Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1090 |