BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇯🇵 Japan

    SK S-RAY GRIDS

    K Number: K945697 · Decision Jan 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    SK S-RAY GRIDS
    K Number
    K945697
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1910
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seibu Techno Coproration
    Date Received
    November 17, 1994
    Decision Date
    January 31, 1995
    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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