BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    IntelliVue Patient monitors MX400, MX450, MX500, MX550

    K Number: K251146 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    48
    Review Days
    186

    Basic Information

    Device Name
    IntelliVue Patient monitors MX400, MX450, MX500, MX550
    K Number
    K251146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boeblingen GmbH
    Date Received
    April 14, 2025
    Decision Date
    October 17, 2025
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Philips Medizin Systeme Boeblingen GmbH

    K Number Device Name
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    K231671 IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
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    K212208 Philips IntelliVue GuardianSoftware (Rev. E.0X)
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    K190624 EarlyVue VS30
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