K922752 is an FDA 510(k) clearance for the STARKEY LABORATORIES OTOSCOPE. This device is classified as a Otoscope (Class I - General Controls, product code ERA).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 4, 1992, 88 days after receiving the submission on June 8, 1992.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 510(k) Number | K922752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1992 |
| Decision Date | September 04, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ERA - Otoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4770 |