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

    S.E.T. TUBE

    K Number: K843988 · Decision Feb 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    S.E.T. TUBE
    K Number
    K843988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bfw Laboratories, Inc.
    Date Received
    October 11, 1984
    Decision Date
    February 21, 1985
    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 Bfw Laboratories, Inc.

    K Number Device Name
    K851462 BFW VOICE GENERATOR