K852422 is an FDA 510(k) clearance for the MODEL 500 PEDIATRIC STRETCHER/CRIB. This device is classified as a Bed, Pediatric Open Hospital (Class II - Special Controls, product code FMS).
Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 5, 1985, 28 days after receiving the submission on June 7, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5140.
| 510(k) Number | K852422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1985 |
| Decision Date | July 05, 1985 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMS — Bed, Pediatric Open Hospital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5140 |