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510(k) Data Aggregation

    K Number
    K133111
    Device Name
    KINGTECH DIGITAL THERMOMETER
    Date Cleared
    2013-12-26

    (87 days)

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

    KINGTECH ENTERPRISE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TT1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
    Device Description
    The Digital Thermometer TT1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with disposable probe cover when taking temperature. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
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    K Number
    K133113
    Device Name
    KINGTECH FOREHEAD THERMOMETER
    Date Cleared
    2013-12-26

    (87 days)

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

    KINGTECH ENTERPRISE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TF1265, TF1267 Forehead Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature fro the surface of human skin without contact. It is for use by people of all ages in the homecare environment.
    Device Description
    The Forehead Thermometer TF1265, TF1267 is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
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    K Number
    K102935
    Device Name
    INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
    Date Cleared
    2011-05-27

    (235 days)

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

    KINGTECH ENTERPRISE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KINGTECH Infrared Ear Thermometer, models: TM810B, TM810B, TM817, TM818, TM818A, TM819, and TM820 are battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The devices are reusable and intended for home use on people at all ages.
    Device Description
    The Infrared Ear Thermometer, models TM810B, TM810B, TM817, TM818, TM818A, TM819 and TM820 is a handheld electronic thermometer that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC)- controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprised of a thermopile for the measuring sensor, a reference thermometer for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0V DC battery (2*AAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display.
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