510(k) K895032

ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES by Zmi Corp. — Product Code LDD

K895032 is an FDA 510(k) premarket notification submitted by Zmi Corp. for the device "ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES". The FDA issued a decision of Substantially Equivalent on October 12, 1989. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Zmi Corp. has at least 7 other 510(k) clearances on record.