510(k) K032691

ZOLL AUTOCLAVABLE INTERNAL HANDLES by Zoll Medical Corp — Product Code LDD

K032691 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "ZOLL AUTOCLAVABLE INTERNAL HANDLES". The FDA issued a decision of Substantially Equivalent on November 13, 2003. 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.