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510(k) Data Aggregation

    K Number
    K100843
    Device Name
    ABREU, MODEL 700
    Date Cleared
    2010-08-17

    (145 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAIN TUNNELGENIX TECHNOLOGIES CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Abreu BTT 700 System is intended for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.
    Device Description
    The Abreu BTT 700 is a device used to measure the temperature of the skin by means of a thermistor coupled with an electronic signal amplification, conditioning, and display unit. As part of its basic design, the thermistor probe is an integral part of a non-disposable "Pen" (covered by a condom), and a disposable "finger." The components of the Abreu BTT 700 consist of a "pen", a disposable "finger", an Interface Module, and a USB A to USB mini cable. The Abreu BTT 700's Interface Module incorporates an onboard computer processing unit which is controlled by a permanently installed software program. Electronic signals received from the thermistor are processed in the Interface Module. With the aid of a computer assisted program, the output is a digital and analog temperature readout. The digital readout is in Celsius and Fahrenheit. The digital analog display is a 270° circular dial illustrating 16-40°C in tenths of a degree
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