MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM

MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K090087) manufactured by Iradimed Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2009. Regulation: 8.