510(k) K053263

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 by Cardionet, Inc. — Product Code DSI

K053263 is an FDA 510(k) premarket notification submitted by Cardionet, Inc. for the device "CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003". The FDA issued a decision of Substantially Equivalent on April 25, 2006. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Cardionet, Inc. has at least 6 other 510(k) clearances on record.