K051861 is an FDA 510(k) clearance for the THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).
Submitted by Savion Industries, Ltd. (Ashdod, IL). The FDA issued a Cleared decision on September 28, 2005, 83 days after receiving the submission on July 7, 2005.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K051861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2005 |
| Decision Date | September 28, 2005 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INK — Stretcher, Wheeled, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3690 |