510(k) K925581

BAXTER BIOSTAT 1000 UREA MONITOR by Baxter Healthcare Corp — Product Code KXM

K925581 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER BIOSTAT 1000 UREA MONITOR". The FDA issued a decision of Substantially Equivalent on May 3, 1995. The device falls under product code KXM (System Accessories, Extracorporeal), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.