K931876 is an FDA 510(k) clearance for the FISK ARM SUPPORT. This device is classified as a Table, Operating-room, Pneumatic (Class I - General Controls, product code FWW).
Submitted by Vvortex International Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on September 9, 1993, 148 days after receiving the submission on April 14, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K931876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1993 |
| Decision Date | September 09, 1993 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FWW — Table, Operating-room, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |