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

    ENDOBRONCHIAL TWIN LUMEN TUBE

    K Number: K834565 · Decision Jan 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    20
    Review Days
    20

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    Basic Information

    Device Name
    ENDOBRONCHIAL TWIN LUMEN TUBE
    K Number
    K834565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Portex, Inc.
    Date Received
    December 28, 1983
    Decision Date
    January 17, 1984
    Product Code
    BTS
    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
    BTS Tube, Bronchial (W/Wo Connector)

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