K935949 is an FDA 510(k) clearance for the STRYKER 5000. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).
Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on June 17, 1994, 186 days after receiving the submission on December 13, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.
| 510(k) Number | K935949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1993 |
| Decision Date | June 17, 1994 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FNM — Mattress, Air Flotation, Alternating Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5550 |