K011181 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR OAE WITH TYMP. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on June 25, 2001, 68 days after receiving the submission on April 18, 2001.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K011181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2001 |
| Decision Date | June 25, 2001 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWO — Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |