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510(k) Data Aggregation

    K Number
    K211352
    Device Name
    Electronic Thermometer (XHF2001, XHF2002)
    Date Cleared
    2021-09-09

    (129 days)

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

    Putian Hanjiang Huafeng Plastic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.
    Device Description
    The Electronic Thermometer is hand-held, predictive, thermistor-based, stick themometer capable of measuring temperature. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the themistor changes tem perature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the the thermometer. This temperature, following the use of the predictive a lgorithm, is then displayed to theend user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset. The Electronic Thermometer comprises a probe which includes a thermistor for getting temperature signal, a buzzer for sounding effect, an build-in software for processing the target temperature digitally, battery compartment with cover, a LCD for displaying the temperature result and indicator information, and a Power (On/Off) switch key. There are two models of Electronic Thermometer, XHF2002. The two models share same specification, main components (such as LCD, probe, electric circuit and CPU), the only differences are size and appearance. The size XHF2001 is 105 x 22 x 12 mm, and the XHF2002 is 125 x 18 x 9.5 mm.
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