510(k) K001629

DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM by Disetronic Medical Systems AG — Product Code FRN

K001629 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on June 21, 2000. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.