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

    VENNER TRACHEAL SEAL MONITOR

    K Number: K110631 · Decision Jul 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    146

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    Basic Information

    Device Name
    VENNER TRACHEAL SEAL MONITOR
    K Number
    K110631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Venner Medical (Singapore) Pte, Ltd.
    Date Received
    March 4, 2011
    Decision Date
    July 28, 2011
    Product Code
    BSK
    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
    BSK Cuff, Tracheal Tube, Inflatable

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    Other Clearances by Venner Medical (Singapore) Pte, Ltd.

    K Number Device Name
    K192511 Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
    K192120 Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
    K191602 APA Oxy Blade
    K100950 VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
    K093135 VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE