510(k) K032789

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 by American I.V. Products, Inc. — Product Code FRN

K032789 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. for the device "REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469". The FDA issued a decision of Substantially Equivalent on October 9, 2003. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. American I.V. Products, Inc. has at least 6 other 510(k) clearances on record.