510(k) K871136

HEARTSTART 2000, MANUAL DEFIBRILLATOR by First Medical Devices Corp. — Product Code LDD

K871136 is an FDA 510(k) premarket notification submitted by First Medical Devices Corp. for the device "HEARTSTART 2000, MANUAL DEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on May 12, 1987. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. First Medical Devices Corp. has at least 6 other 510(k) clearances on record.