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

    MONTGOMERY TRACHEAL T-TUBE

    K Number: K841266 · Decision Jun 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    80

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    Basic Information

    Device Name
    MONTGOMERY TRACHEAL T-TUBE
    K Number
    K841266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    E. Benson Hood Laboratories, Inc.
    Date Received
    March 26, 1984
    Decision Date
    June 14, 1984
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by E. Benson Hood Laboratories, Inc.

    K Number Device Name
    K983878 CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
    K841350 SALIVARY BYPASS TUBE
    K841349 ESOPHAGEAL TUBE
    K841347 LARYNGEAL STENT
    K841348 UMBRELLA KEEL