510(k) K853393

INSULIN PUMP INSUMAT 229 by Medix Medical Electronics (U.S.A.), Inc. — Product Code FRN

K853393 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "INSULIN PUMP INSUMAT 229". The FDA issued a decision of Substantially Equivalent on November 18, 1985. 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.