K850959 is an FDA 510(k) clearance for the EQUIPMENT SNAP KOVERS. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on April 9, 1985, 32 days after receiving the submission on March 8, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K850959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1985 |
| Decision Date | April 09, 1985 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |