510(k) K103159

CARDIO MED MODEL A102, H104, O101, P103, AND Z100 by Cardio Medical Products, Inc. — Product Code LDD

K103159 is an FDA 510(k) premarket notification submitted by Cardio Medical Products, Inc. for the device "CARDIO MED MODEL A102, H104, O101, P103, AND Z100". The FDA issued a decision of Substantially Equivalent on January 11, 2011. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Cardio Medical Products, Inc. has at least 2 other 510(k) clearances on record.