K961437 is an FDA 510(k) clearance for the WHEELED STRETCHER. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on June 3, 1996, 49 days after receiving the submission on April 15, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K961437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1996 |
| Decision Date | June 03, 1996 |
| Days to Decision | 49 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 |