510(k) K152330

Expression MR400 MRI Patient Monitoring System by Invivo Corporation — Product Code MWI

K152330 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "Expression MR400 MRI Patient Monitoring System". The FDA issued a decision of Substantially Equivalent on December 23, 2015. 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. Invivo Corporation has at least 10 other 510(k) clearances on record.