K861516 is an FDA 510(k) clearance for the WELCH ALLYN TYMPANOMETER. This device is classified as a Tester, Auditory Impedance (Class II - Special Controls, product code ETY).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 10, 1986, 48 days after receiving the submission on April 23, 1986.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1090.
| 510(k) Number | K861516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 1986 |
| Decision Date | June 10, 1986 |
| Days to Decision | 48 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 |