510(k) K971840

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM by Invivo Research, Inc. — Product Code MHX

K971840 is an FDA 510(k) premarket notification submitted by Invivo Research, Inc. for the device "OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1998. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Invivo Research, Inc. has at least 10 other 510(k) clearances on record.