K983350 is an FDA 510(k) clearance for the ILO292 DP ECHOPORT PLUS OAE SYSTEM. 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 December 11, 1998, 79 days after receiving the submission on September 23, 1998.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K983350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1998 |
| Decision Date | December 11, 1998 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | EWO - Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |