510(k) K011000

TRAM 2001 MODULE by General Electric Medical Systems Information Techn — Product Code MHX

K011000 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "TRAM 2001 MODULE". The FDA issued a decision of Substantially Equivalent on June 29, 2001. 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.