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

    PHILIPS AVALON FETAL MONITORS FM20 AND FM30

    K Number: K071800 · Decision Sep 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    210
    Applicant Total
    25
    Review Days
    87

    Basic Information

    Device Name
    PHILIPS AVALON FETAL MONITORS FM20 AND FM30
    K Number
    K071800
    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 MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
    Date Received
    July 2, 2007
    Decision Date
    September 27, 2007
    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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