510(k) K003707

CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A by Cardionet — Product Code MWJ

K003707 is an FDA 510(k) premarket notification submitted by Cardionet for the device "CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Cardionet has at least 6 other 510(k) clearances on record.