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

    PROGNOST ES, MODEL 0302 0000

    K Number: K011290 · Decision May 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    33

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    Basic Information

    Device Name
    PROGNOST ES, MODEL 0302 0000
    K Number
    K011290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xmar Corp.
    Date Received
    April 27, 2001
    Decision Date
    May 30, 2001
    Product Code
    IZF
    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
    IZF System, X-Ray, Tomographic

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