K884218 is an FDA 510(k) clearance for the AUDIOSCOPE 3 MODEL 23300 ACCESSORIES. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 10, 1989, 155 days after receiving the submission on October 6, 1988.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K884218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1988 |
| Decision Date | March 10, 1989 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWO — Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |