K951647 is an FDA 510(k) clearance for the WELCH ALLYN HI - LUX ILLUMINATOR. This device is classified as a Light Source, Fiberoptic, Routine (Class II - Special Controls, product code FCW).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on May 17, 1995, 37 days after receiving the submission on April 10, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K951647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1995 |
| Decision Date | May 17, 1995 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |