510(k) K131588

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR by Edwards Lifesciences, LLC — Product Code DXG

K131588 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR". The FDA issued a decision of Substantially Equivalent on May 22, 2014. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.