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

    CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V

    K Number: K082038 · Decision Apr 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    10
    Review Days
    285

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    Basic Information

    Device Name
    CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
    K Number
    K082038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical, LLC
    Date Received
    July 17, 2008
    Decision Date
    April 28, 2009
    Product Code
    BTR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTR Tube, Tracheal (W/Wo Connector)

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