K060539 is an FDA 510(k) clearance for the DPOAE20 , ECLIPSE. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Interacoustics A/S, Assens (Minnesota, US). The FDA issued a Cleared decision on May 30, 2006, 90 days after receiving the submission on March 1, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K060539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2006 |
| Decision Date | May 30, 2006 |
| Days to Decision | 90 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 |