K943864 is an FDA 510(k) clearance for the STRYKER 8000 SURGERY STRETCHER. 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 August 25, 1994, 17 days after receiving the submission on August 8, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K943864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1994 |
| Decision Date | August 25, 1994 |
| Days to Decision | 17 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 |