510(k) K122090

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code MXC

K122090 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "SJM CONFIRM IMPLANTABLE CARDIAC MONITOR". The FDA issued a decision of Substantially Equivalent on November 15, 2012. 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, Cardiac Rhythm Management Divisi has at least 9 other 510(k) clearances on record.