K952835 is an FDA 510(k) clearance for the WELCH ALLYN VIDEO EPISCOPE. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on September 22, 1995, 94 days after receiving the submission on June 20, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K952835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1995 |
| Decision Date | September 22, 1995 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZF — Device, Medical Examination, Ac Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6320 |