K952289 is an FDA 510(k) clearance for the WELCH ALLYN FIBER OPTIC HEADLIGNT. This device is classified as a Headlamp, Operating, Ac-powered (Class II - Special Controls, product code HPQ).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 14, 1995, 59 days after receiving the submission on May 16, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4335.
| 510(k) Number | K952289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1995 |
| Decision Date | July 14, 1995 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPQ — Headlamp, Operating, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4335 |