BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Changer, Tube, Endotracheal

    PMA: P800068 · Supplement: S002 · Decision Nov 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Changer, Tube, Endotracheal
    Trade Name
    ENDOTRACHEAL TUBE CHANGERS
    PMA Number
    P800068
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    LNZ
    Generic Name
    Changer, tube, endotracheal
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 4, 1999
    Date Received
    September 3, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at FBK Medical Tubing, Inc., 511 Cobb St., Birmingham, AL 35209.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNZ Changer, Tube, Endotracheal