BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    FIBRE INTERSPACED X-RAY GRID

    K Number: K963893 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    FIBRE INTERSPACED X-RAY GRID
    K Number
    K963893
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1910
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smit Rontgen
    Date Received
    September 27, 1996
    Decision Date
    November 7, 1996
    Product Code
    IXJ
    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
    IXJ Grid, Radiographic

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