510(k) K050399

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 by Invivo Research, Inc. — Product Code MWI

K050399 is an FDA 510(k) premarket notification submitted by Invivo Research, Inc. for the device "MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160". The FDA issued a decision of Substantially Equivalent on August 26, 2005. 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 Research, Inc. has at least 10 other 510(k) clearances on record.