510(k) K010923

KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E by Siemens Elema AB — Product Code MHX

K010923 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E". The FDA issued a decision of Substantially Equivalent on January 23, 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. Siemens Elema AB has at least 10 other 510(k) clearances on record.