K072033 is an FDA 510(k) clearance for the OTODYNAMICS OTOPORT. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Otodynamics, Ltd. (Crofton, US). The FDA issued a Cleared decision on November 13, 2007, 112 days after receiving the submission on July 24, 2007.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K072033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2007 |
| Decision Date | November 13, 2007 |
| Days to Decision | 112 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 |