K923730 is an FDA 510(k) clearance for the MODEL 561 C-ARM PROCEDURES STRETCHER. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).
Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on February 9, 1994, 562 days after receiving the submission on July 27, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.
| 510(k) Number | K923730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1992 |
| Decision Date | February 09, 1994 |
| Days to Decision | 562 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 |