K781029 is an FDA 510(k) clearance for the OTOSCOPE, DIAG. MODELS 20100 & 20200. 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 June 28, 1978, 9 days after receiving the submission on June 19, 1978.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 510(k) Number | K781029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1978 |
| Decision Date | June 28, 1978 |
| Days to Decision | 9 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 |