K831709 is an FDA 510(k) clearance for the AUDIOSCOPE #23000 W/71123 CHARGING STAND. This device is classified as a Otoscope (Class I - General Controls, product code ERA).
Submitted by Welch Allyn, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983, 35 days after receiving the submission on May 26, 1983.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 510(k) Number | K831709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1983 |
| Decision Date | June 30, 1983 |
| Days to Decision | 35 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 |