510(k) K143369

MRidium 3860+ MRI infusion Pump/ Monitoring System by Iradimed Corporation — Product Code FRN

K143369 is an FDA 510(k) premarket notification submitted by Iradimed Corporation for the device "MRidium 3860+ MRI infusion Pump/ Monitoring System". The FDA issued a decision of Substantially Equivalent on December 15, 2016. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Iradimed Corporation has at least 6 other 510(k) clearances on record.