510(k) K911455

MODEL #100 SHOCK-TRODE CHILD DEFIB PADS by Cardiotronics, Inc. — Product Code LDD

K911455 is an FDA 510(k) premarket notification submitted by Cardiotronics, Inc. for the device "MODEL #100 SHOCK-TRODE CHILD DEFIB PADS". The FDA issued a decision of Substantially Equivalent on October 16, 1991. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Cardiotronics, Inc. has at least 10 other 510(k) clearances on record.