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510(k) Data Aggregation

    K Number
    K102127
    Device Name
    ENDOTRACHEAL TUBE CHANGERS
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2010-08-27

    (29 days)

    Product Code
    LNZ
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    LNZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.
    Device Description
    The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.
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