510(k) K903657

MODEL 610 MODIFIED by First Medical Devices Corp. — Product Code LDD

K903657 is an FDA 510(k) premarket notification submitted by First Medical Devices Corp. for the device "MODEL 610 MODIFIED". The FDA issued a decision of Substantially Equivalent on September 4, 1990. 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.