510(k) K253277

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P by Ge Medical Systems Information Technologies, Inc. — Product Code MHX

K253277 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P". The FDA issued a decision of Substantially Equivalent on July 24, 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 Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.