K962995 is an FDA 510(k) clearance for the ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Otodynamics, Ltd. (Hatfield Herts Al10 8bb, GB). The FDA issued a Cleared decision on January 10, 1997, 162 days after receiving the submission on August 1, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K962995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1996 |
| Decision Date | January 10, 1997 |
| Days to Decision | 162 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 |