K931946 is an FDA 510(k) clearance for the WELCH ALLYN EARCLEANER. This device is classified as a Syringe, Irrigating (non Dental) (Class I - General Controls, product code KYZ).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 26, 1993, 98 days after receiving the submission on April 19, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.
| 510(k) Number | K931946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1993 |
| Decision Date | July 26, 1993 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KYZ — Syringe, Irrigating (non Dental) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6960 |