510(k) K021325

MODIFICATION OF APEXPRO TELEMETRY SYSTEM by General Electric Medical Systems Information Techn — Product Code MHX

K021325 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "MODIFICATION OF APEXPRO TELEMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 2002. 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. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.