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

    MODEL 8100 PRE-FILLED INTRAUTERINE

    K Number: K790418 · Decision Mar 21, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    136
    Review Days
    21

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    Basic Information

    Device Name
    MODEL 8100 PRE-FILLED INTRAUTERINE
    K Number
    K790418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    February 28, 1979
    Decision Date
    March 21, 1979
    Product Code
    KXO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXO Monitor, Pressure, Intrauterine

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