K952691 is an FDA 510(k) clearance for the WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT. This device is classified as a Detector, Blood Level (Class II - Special Controls, product code FJC).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 31, 1995, 49 days after receiving the submission on June 12, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K952691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1995 |
| Decision Date | July 31, 1995 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJC — Detector, Blood Level |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |