K940616 is an FDA 510(k) clearance for the SKYTRON ELITE 3500 TABLE. This device is classified as a Table, Operating-room, Electrical (Class I — General Controls, product code GDC).
Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on June 13, 1994, 119 days after receiving the submission on February 14, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K940616 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 1994 |
| Decision Date | June 13, 1994 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDC — Table, Operating-room, Electrical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |