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

    ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE

    K Number: K030960 · Decision Jul 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    16
    Review Days
    111

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    Basic Information

    Device Name
    ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
    K Number
    K030960
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acmi Corporation
    Date Received
    March 27, 2003
    Decision Date
    July 16, 2003
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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