510(k) K113441

PHYSIOLOGICAL MONITOR, PATIENT MONITOR by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

K113441 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "PHYSIOLOGICAL MONITOR, PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on March 22, 2012. 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. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.