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510(k) Data Aggregation

    K Number
    K963177
    Device Name
    TED 191
    Manufacturer
    TELEDYNE BROWN ENGINEERING
    Date Cleared
    1997-11-13

    (456 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEDYNE BROWN ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas). The device is primarily intended for use in medical applications such as oxygen therapy and ventilatory monitoring, although it may be used in ancillary applications such as checking the purity of compressed air and oxygen, or mixes thereof.
    Device Description
    The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas).
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