K083576 is an FDA 510(k) clearance for the MISER CONTRAST MANAGEMENT SYSTEM. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 23, 2008, 20 days after receiving the submission on December 3, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K083576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2008 |
| Decision Date | December 23, 2008 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |