510(k) K101968

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A by St Jude Medical — Product Code MXC

K101968 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A". The FDA issued a decision of Substantially Equivalent on September 15, 2010. 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.