510(k) K260656

Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M by GE Healthcare Finland Oy — Product Code MHX

K260656 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M". The FDA issued a decision of Substantially Equivalent on September 1, 2026. 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.