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

    UNCUFFED REINFORCED TRACHEAL TUBE

    K Number: K841872 · Decision Jul 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    236
    Applicant Total
    92
    Review Days
    80

    Basic Information

    Device Name
    UNCUFFED REINFORCED TRACHEAL TUBE
    K Number
    K841872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    MALLINCKRODT CRITICAL CARE
    Date Received
    May 7, 1984
    Decision Date
    July 26, 1984
    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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