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

    NON STRESS TEST MONITOR 507

    K Number: K840285 · Decision May 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    19
    Review Days
    106

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    Basic Information

    Device Name
    NON STRESS TEST MONITOR 507
    K Number
    K840285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5070
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Imex Medical Systems, Inc.
    Date Received
    January 24, 1984
    Decision Date
    May 9, 1984
    Product Code
    HGH
    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
    HGH Cannula, Suction, Uterine

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