K060883 is an FDA 510(k) clearance for the PILOT TEST OR DETECTIVE AUDIOMETERS. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Interacoustics A/S (Minnesota, US). The FDA issued a Cleared decision on June 23, 2006, 84 days after receiving the submission on March 31, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K060883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2006 |
| Decision Date | June 23, 2006 |
| Days to Decision | 84 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 |