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

    PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50

    K Number: K140535 · Decision Nov 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    12
    Review Days
    266

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    Basic Information

    Device Name
    PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
    K Number
    K140535
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boblingen GmbH
    Date Received
    March 4, 2014
    Decision Date
    November 25, 2014
    Product Code
    HGM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGM System, Monitoring, Perinatal

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    Other Clearances by Philips Medizin Systeme Boblingen GmbH

    K Number Device Name
    K151736 Philips IntelliVue GuardianSoftware
    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
    K083228 PHILIPS INTELLIVUE MP5 PATIENT MONITOR
    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 →