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

    Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

    K Number: K153206 · Decision Mar 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    71
    Review Days
    119

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    Basic Information

    Device Name
    Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
    K Number
    K153206
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical System U.S.A., Inc.
    Date Received
    November 5, 2015
    Decision Date
    March 3, 2016
    Product Code
    FDS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FDS Gastroscope And Accessories, Flexible/Rigid

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