510(k) K124061

MRI PATIENT MONITORING SYSTEM (MODEL 865214) by Invivo Corporation — Product Code MWI

K124061 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "MRI PATIENT MONITORING SYSTEM (MODEL 865214)". The FDA issued a decision of Substantially Equivalent on February 22, 2013. 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.