510(k) K251146

IntelliVue Patient monitors MX400, MX450, MX500, MX550 by Philips Medizin Systeme Boeblingen GmbH — Product Code MHX

K251146 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "IntelliVue Patient monitors MX400, MX450, MX500, MX550". The FDA issued a decision of Substantially Equivalent on October 17, 2025. 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.