510(k) K900498

MODIFIED BETATRON IV INSULIN INFUSION SYSTEM by Cardiac Pacemakers, Inc. — Product Code LZG

K900498 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "MODIFIED BETATRON IV INSULIN INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 23, 1990. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.