K143395 is an FDA 510(k) clearance for the Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Otodynamics, Ltd. (Hatfield, Herts, GB). The FDA issued a Cleared decision on February 23, 2015, 89 days after receiving the submission on November 26, 2014.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K143395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2014 |
| Decision Date | February 23, 2015 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWO - Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |