510(k) K001268

GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS by General Electric Medical Systems Information Techn — Product Code MHX

K001268 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS". The FDA issued a decision of Substantially Equivalent on July 17, 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.