510(k) K002604

CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM by Invivo Research, Inc. — Product Code DSI

K002604 is an FDA 510(k) premarket notification submitted by Invivo Research, Inc. for the device "CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2002. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Invivo Research, Inc. has at least 10 other 510(k) clearances on record.