510(k) K991376

DAHEDI INSULIN INFUSION PUMP by Disetronic Medical Systems — Product Code LZG

K991376 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems for the device "DAHEDI INSULIN INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on June 15, 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.