K935297 is an FDA 510(k) clearance for the STRYKER AMBULANCE COT MODEL 6060. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).
Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on February 18, 1994, 108 days after receiving the submission on November 2, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K935297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1993 |
| Decision Date | February 18, 1994 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPO — Stretcher, Wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6910 |