510(k) K213490

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

K213490 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 April 1, 2022. 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.