510(k) K192137

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 by Philips Medizin Systeme Boeblingen GmbH — Product Code MHX

K192137 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550". The FDA issued a decision of Substantially Equivalent on September 11, 2020. 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 Boeblingen GmbH has at least 10 other 510(k) clearances on record.