510(k) K143676

B40i Patient Monitor by GE Healthcare Finland Oy — Product Code MHX

K143676 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "B40i Patient Monitor". The FDA issued a decision of Substantially Equivalent on July 31, 2015. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. GE Healthcare Finland Oy has at least 10 other 510(k) clearances on record.