510(k) K896903

FIRST MEDIC MODEL 510 by Spacelabs, Inc. — Product Code LDD

K896903 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "FIRST MEDIC MODEL 510". The FDA issued a decision of Substantially Equivalent on December 27, 1990. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.