K933564 is an FDA 510(k) clearance for the SKYTRON EXAM LIGHT. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).
Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 10, 1994, 203 days after receiving the submission on July 22, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K933564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1993 |
| Decision Date | February 10, 1994 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KZF — Device, Medical Examination, Ac Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6320 |