510(k) K994186

DISETRONIC D-TRON INSULIN INFUSION PUMP by Disetronic Medical Systems — Product Code LZG

K994186 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems for the device "DISETRONIC D-TRON INSULIN INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on December 30, 1999. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems has at least 10 other 510(k) clearances on record.