510(k) K870444

HOMEPRO II VOLUMETRIC INFUSION PUMP by American Edwards Laboratories — Product Code FRN

K870444 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "HOMEPRO II VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on April 17, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. American Edwards Laboratories has at least 10 other 510(k) clearances on record.