K050301 is an FDA 510(k) clearance for the MRIDIUM 3850 MRI PUMP 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 March 24, 2005, 44 days after receiving the submission on February 8, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K050301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2005 |
| Decision Date | March 24, 2005 |
| Days to Decision | 44 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 |