510(k) K042302

ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE by Zoll Medical Corp — Product Code LDD

K042302 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE". The FDA issued a decision of Substantially Equivalent on October 26, 2004. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Zoll Medical Corp has at least 10 other 510(k) clearances on record.