510(k) K083228

PHILIPS INTELLIVUE MP5 PATIENT MONITOR by Philips Medizin Systeme Boblingen GmbH — Product Code MHX

K083228 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boblingen GmbH for the device "PHILIPS INTELLIVUE MP5 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on November 24, 2008. 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 Medizin Systeme Boblingen GmbH has at least 10 other 510(k) clearances on record.