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

    IMAGE1 GI CCU MODEL 22203020-114

    K Number: K111997 · Decision Apr 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    95
    Applicant Total
    318
    Review Days
    268

    Basic Information

    Device Name
    IMAGE1 GI CCU MODEL 22203020-114
    K Number
    K111997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Received
    July 13, 2011
    Decision Date
    April 6, 2012
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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