510(k) K955816

VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR by Baxter Healthcare Corp — Product Code DYG

K955816 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.