510(k) K062457

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES by Baxter Healthcare Corporation — Product Code MEB

K062457 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES". The FDA issued a decision of Substantially Equivalent on September 21, 2006. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.