K890124 is an FDA 510(k) clearance for the ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Grason-Stadler, Inc. (Littleton, US). The FDA issued a Cleared decision on July 14, 1989, 184 days after receiving the submission on January 11, 1989.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K890124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1989 |
| Decision Date | July 14, 1989 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWO — Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |