510(k) K133801

BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY by Baxter Healthcare Corporation — Product Code FRN

K133801 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY". The FDA issued a decision of Substantially Equivalent on May 7, 2014. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.