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

    RADKOR, RF-159

    K Number: K883885 · Decision Oct 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    30
    Applicant Total
    10
    Review Days
    36

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    Basic Information

    Device Name
    RADKOR, RF-159
    K Number
    K883885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Radkor, Inc.
    Date Received
    September 13, 1988
    Decision Date
    October 19, 1988
    Product Code
    KXJ
    Advisory Committee
    Radiology
    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
    KXJ Table, Radiologic

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