K113598 is an FDA 510(k) clearance for the POWER-LOAD COT FASTENER SYSTEM. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).
Submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on December 20, 2011, 15 days after receiving the submission on December 5, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K113598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2011 |
| Decision Date | December 20, 2011 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPO — Stretcher, Wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6910 |