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510(k) Data Aggregation

    K Number
    K070878
    Device Name
    DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
    Date Cleared
    2007-06-05

    (68 days)

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

    RG MEDICAL DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DataTherm® II Continuous Temperature Monitor is intended to continuously measure, display and monitor human body temperature updating every 4 seconds. Additionally, it stores up to 140 temperature/time/day data sets that may be stored at a user-selected frequency range from once per minute to once every 24 hours in one minute intervals. The current temperature and stored information may be viewed on the LCD screen that is integrated into the instrument or, from a PC computer screen after installation of the DataTherm software to a PC. The DataTherm II is intended to be used on patients of all ages. The DataTherm® II Continuous Temperature Monitor is used to measure and monitor human body temperature and for storing temperature data at adjustable, preset time intervals.
    Device Description
    The DataTherm II Continuous Temperature Monitor (model HD-2300) consists of four components. - 1. A control / display assembly measuring 3.16'' X 2.37' X 0.71" with an LCD screen and 5 control keys (On/Off, Mode Selection, &(increase), (decrease) and keyboard Lock). The interior electronic components consist of a circuit board, a battery compartment housing 2 - AAA batteries, a buzzer and LED alert light. - 2. A disposable flexible temperature probe having a plug-in connector at one end and thermistor sensor at the other. - 3. A USB interface connector cable that permits the transfer of stored and real-time temperature/time/day information to a PC computer screen. - 4. Proprietary software that permits an individual patient's current temperature to be viewed and temperature/time/date information to be displayed and archived, if desired.
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