K143369 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 Springs, US). The FDA issued a Cleared decision on December 15, 2016, 751 days after receiving the submission on November 25, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K143369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2014 |
| Decision Date | December 15, 2016 |
| Days to Decision | 751 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 |