510(k) K223531

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) by GE Healthcare Finland Oy — Product Code MHX

K223531 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)". The FDA issued a decision of Substantially Equivalent on April 6, 2023. 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.