K946060 is an FDA 510(k) clearance for the REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Remington Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on April 27, 1995, 146 days after receiving the submission on December 2, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K946060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1994 |
| Decision Date | April 27, 1995 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX - Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |