510(k) K861001

PARENTERAL INFUSER MEDIPUMP 204 by Medix Medical Electronics (U.S.A.), Inc. — Product Code FRN

K861001 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "PARENTERAL INFUSER MEDIPUMP 204". The FDA issued a decision of Substantially Equivalent on June 12, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.