510(k) K002209

GE MARQUETTE ECG ANALYSIS PROGRAM by General Electric Medical Systems Information Techn — Product Code MHX

K002209 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "GE MARQUETTE ECG ANALYSIS PROGRAM". The FDA issued a decision of Substantially Equivalent on August 18, 2000. 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.