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

    ABDOMINAL FETAL ECG MODULE

    K Number: K770245 · Decision Feb 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    7

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    Basic Information

    Device Name
    ABDOMINAL FETAL ECG MODULE
    K Number
    K770245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2600
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Mennen Greatbatch Electonics
    Date Received
    February 7, 1977
    Decision Date
    February 14, 1977
    Product Code
    KXN
    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
    KXN Monitor, Cardiac, Fetal

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