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510(k) Data Aggregation

    K Number
    K032612
    Device Name
    IR FOREHEAD THERMOMETER, MODEL HV-T36
    Date Cleared
    2004-02-19

    (178 days)

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

    ORIENTAL INSPIRATION LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
    Device Description
    This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF). This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift. HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.
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