K934259 is an FDA 510(k) clearance for the AC-POWERED MEDICAL EXAMINATION LIGHT. 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 January 28, 1994, 150 days after receiving the submission on August 31, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K934259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1993 |
| Decision Date | January 28, 1994 |
| Days to Decision | 150 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 |