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

    VivaSight-SL (TVT) system

    K Number: K181880 · Decision Nov 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    VivaSight-SL (TVT) system
    K Number
    K181880
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Etview , Ltd.
    Date Received
    July 13, 2018
    Decision Date
    November 29, 2018
    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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    Other Clearances by Etview , Ltd.

    K Number Device Name
    K181886 VivaSight-DL 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