BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    NAVIAID BGE DEVICE, MODEL 21-001

    K Number: K060923 · Decision Aug 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    133

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    Basic Information

    Device Name
    NAVIAID BGE DEVICE, MODEL 21-001
    K Number
    K060923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smart Medical Systems , Ltd.
    Date Received
    April 4, 2006
    Decision Date
    August 15, 2006
    Product Code
    FDA
    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
    FDA Enteroscope And Accessories

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