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510(k) Data Aggregation

    K Number
    K163603
    Device Name
    Digital Thermometer
    Manufacturer
    Guangzhou Jinxinbao Electronic Co., Ltd
    Date Cleared
    2017-06-06

    (167 days)

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

    Guangzhou Jinxinbao Electronic Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.
    Device Description
    The Digital Thermometer utilizes measured thermistor resistance and a microcontroller unit to determine and display human body temperature. Changes in the probe temperature due to oral or auxiliary contact correspond to changes in resistance. The probe Temperature values are digitally displayed on an LCD screen in 0.2 degrees Fahrenheit increments. The measurements do not account for a probe cover. The user contacting materials are Stainless steel and Acrylonitrile Butadiene Styrene (ABS). The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the same basic functions: - Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement - Data displayed in Celsius - - Automatic stop (energy saver) -
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