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

    MONTGOMERY SILICONE TRACHEAL T-TUBE

    K Number: K810978 · Decision May 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    33
    Review Days
    25

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    Basic Information

    Device Name
    MONTGOMERY SILICONE TRACHEAL T-TUBE
    K Number
    K810978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Boston Medical Products, Inc.
    Date Received
    April 10, 1981
    Decision Date
    May 5, 1981
    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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