K090087 is an FDA 510(k) clearance for the MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Iradimed Corporation (Winter Park, US). The FDA issued a Cleared decision on April 7, 2009, 84 days after receiving the submission on January 13, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K090087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2009 |
| Decision Date | April 07, 2009 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |