510(k) K132528

E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES by GE Healthcare Finland Oy — Product Code DXG

K132528 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 16, 2014. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. GE Healthcare Finland Oy has at least 10 other 510(k) clearances on record.