K051324 is an FDA 510(k) clearance for the MEDI BUTLER. This device is classified as a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II - Special Controls, product code DWL).
Submitted by Medi USA, LP (Washington, US). The FDA issued a Cleared decision on December 5, 2005, 199 days after receiving the submission on May 20, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.
| 510(k) Number | K051324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2005 |
| Decision Date | December 05, 2005 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DWL - Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5780 |