510(k) K180903

3880 MRI Patient Monitoring System by Iradimed Corporation — Product Code MWI

K180903 is an FDA 510(k) premarket notification submitted by Iradimed Corporation for the device "3880 MRI Patient Monitoring System". The FDA issued a decision of Substantially Equivalent on March 29, 2019. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Iradimed Corporation has at least 6 other 510(k) clearances on record.