K902068 is an FDA 510(k) clearance for the HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 6, 1990, 91 days after receiving the submission on May 7, 1990.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K902068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1990 |
| Decision Date | August 06, 1990 |
| Days to Decision | 91 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 |