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

    CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045

    K Number: K080613 · Decision Nov 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    247

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    Basic Information

    Device Name
    CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
    K Number
    K080613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minimally Invasive Devices, LLC
    Date Received
    March 4, 2008
    Decision Date
    November 6, 2008
    Product Code
    OCT
    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
    OCT Anti Fog Solution And Accessories, Endoscopy

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    Other Clearances by Minimally Invasive Devices, LLC

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    K102452 DEFOGGING AND CLEANING SOLUTION- FLO-X