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

    MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION

    K Number: K013620 · Decision Jan 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    3
    Review Days
    78

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    Basic Information

    Device Name
    MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
    K Number
    K013620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medstone Intl., Inc.
    Date Received
    November 5, 2001
    Decision Date
    January 22, 2002
    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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