INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL

About This 510(k) Submission

K101600 is an FDA 510(k) clearance for the INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL, a Oximeter (Class II — Special Controls, product code DQA), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on August 31, 2010, 84 days after receiving the submission on June 8, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.