BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NIOBI-X RADIATION REDUCTION FILTER

    K Number: K882939 · Decision Nov 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    NIOBI-X RADIATION REDUCTION FILTER
    K Number
    K882939
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    American Canadian Products, Inc.
    Date Received
    July 13, 1988
    Decision Date
    November 4, 1988
    Product Code
    ITY
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

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