510(k) K081365

SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR by St Jude Medical — Product Code MXC

K081365 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR". The FDA issued a decision of Substantially Equivalent on August 15, 2008. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. St Jude Medical has at least 10 other 510(k) clearances on record.