BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FETASONDE MODEL 2108

    K Number: K790761 · Decision Jun 1, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    16
    Review Days
    45

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    Basic Information

    Device Name
    FETASONDE MODEL 2108
    K Number
    K790761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Roche Medical Electronics, Inc.
    Date Received
    April 17, 1979
    Decision Date
    June 1, 1979
    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 Roche Medical Electronics, Inc.

    K Number Device Name
    K791559 ROCHE SENSOR ADAPTOR
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    K791037 FETASONDE LABOR STATUS DISPLAY
    K791035 FETASONDE FETAL ACTIVITY MONITOR
    K791039 FETASONDE FETAL HEART RATE VARIABILITY
    K790421 ROCHE LACTATE ANALYZER 640
    K782088 MONITOR, HEART RATE MODEL 105
    K782089 MONITOR, HEART RATE MODEL 103
    K781271 MONITOR, PO2, INTRAVASCULAR
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