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

    PHILIPS INTELLIVUE MP5 PATIENT MONITOR

    K Number: K083228 · Decision Nov 24, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    12
    Review Days
    21

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    Basic Information

    Device Name
    PHILIPS INTELLIVUE MP5 PATIENT MONITOR
    K Number
    K083228
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boblingen GmbH
    Date Received
    November 3, 2008
    Decision Date
    November 24, 2008
    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 Boblingen GmbH

    K Number Device Name
    K151736 Philips IntelliVue GuardianSoftware
    K140535 PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
    K113657 INTELLIVUE PATIENT MONITOR
    K102958 PHILIPS AVALON FETAL MONITOR
    K102562 INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
    K090360 PHILIPS M3001A MULTI MEASUREMENT SERVER
    K060541 THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
    K042845 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS
    K032858 THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
    K031481 THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
    Search all 12 clearances from Philips Medizin Systeme Boblingen GmbH →