510(k) K070125

COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION by Baxter Healthcare Corp — Product Code FRN

K070125 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION". The FDA issued a decision of Substantially Equivalent on Apr 16, 2007. 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.