K770769 is an FDA 510(k) clearance for the OTOSCOPE/ILLUMINATOR, MODEL #21100. This device is classified as a Otoscope (Class I - General Controls, product code ERA).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1977, 1 day after receiving the submission on April 28, 1977.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 510(k) Number | K770769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1977 |
| Decision Date | April 29, 1977 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ERA — Otoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4770 |