510(k) K090087

MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM by Iradimed Corporation — Product Code FRN

K090087 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 April 7, 2009. 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.