510(k) K230604

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) by Philips Medizin Systeme Boeblingen GmbH — Product Code MHX

K230604 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)". The FDA issued a decision of Substantially Equivalent on November 22, 2023. 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.