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510(k) Data Aggregation

    K Number
    K030219
    Device Name
    DIGITAL TEMPERATURE MONITOR; MODEL KY-01
    Date Cleared
    2003-08-05

    (195 days)

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

    KANG YING MEDICAL APPLIANCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.
    Device Description
    The Digital temperature monitor, model KY-01, are the electronic thermometers by using a thermistor 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 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. This system uses a 1.5V DC battery 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. Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98.
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