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

    VivaSight-DL System

    K Number: K181886 · Decision Nov 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    124

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    Basic Information

    Device Name
    VivaSight-DL System
    K Number
    K181886
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Etview , Ltd.
    Date Received
    July 13, 2018
    Decision Date
    November 14, 2018
    Product Code
    CBI
    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
    CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

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    Other Clearances by Etview , Ltd.

    K Number Device Name
    K181880 VivaSight-SL (TVT) system
    K152438 ETView VivaSight-SL (TVT) system
    K123853 VIVASIGHT-DL SYSTEM
    K121028 ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
    K120334 VIVA EB
    K113576 DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
    K052233 TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM