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

    TRU-CABLE

    K Number: K063309 · Decision Jan 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    TRU-CABLE
    K Number
    K063309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Truphatek International, Ltd.
    Date Received
    November 2, 2006
    Decision Date
    January 12, 2007
    Product Code
    FFS
    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
    FFS Image, Illumination, Fiberoptic, For Endoscope

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    Other Clearances by Truphatek International, Ltd.

    K Number Device Name
    K062523 TRU-MR LARYNGOSCOPE SET