510(k) K101600

INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code DQA

K101600 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL". The FDA issued a decision of Substantially Equivalent on August 31, 2010. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.