510(k) K002211

COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 by Baxter Healthcare Corp — Product Code FRN

K002211 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151". The FDA issued a decision of Substantially Equivalent on Jul 28, 2000. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has 507 other 510(k) clearances on record.