K943721 is an FDA 510(k) clearance for the OTOVIEW TELESCOPIC OTOSCOPES. This device is classified as a Otoscope (Class I - General Controls, product code ERA).
Submitted by Smith & Nephew, Inc. (Bartlett, US). The FDA issued a Cleared decision on November 18, 1994, 109 days after receiving the submission on August 1, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 510(k) Number | K943721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1994 |
| Decision Date | November 18, 1994 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ERA — Otoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4770 |