510(k) K130711

INFINITY CENTRALSTATION WITH INFINITY M300 by Draeger Medical Systems, Inc. — Product Code MHX

K130711 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "INFINITY CENTRALSTATION WITH INFINITY M300". The FDA issued a decision of Substantially Equivalent on April 11, 2013. 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. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.