K151616 is an FDA 510(k) clearance for the AT235. This device is classified as a Tester, Auditory Impedance (Class II - Special Controls, product code ETY).
Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on July 15, 2015, 30 days after receiving the submission on June 15, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1090.
| 510(k) Number | K151616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2015 |
| Decision Date | July 15, 2015 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETY - Tester, Auditory Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1090 |