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510(k) Data Aggregation

    K Number
    K120671
    Device Name
    DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
    Date Cleared
    2013-05-17

    (438 days)

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

    COTRONIC TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Digital Pacifier Thermometer TM-03 is a non-sterile, reusable & battery-operated clinical electronic thermometer for use by medical professional or at home. The TM-03 is intended to measure the oral temperature of infant to children up to 5 years old.
    Device Description
    Digital Pacifier Thermometer TM-03 is a reusable, battery-operated clinical electronic thermometer, with which a thermistor installed inside the nipple, for use by medical professional or at home. Different from the traditional electronic thermometer, our TM-03 is designed specifically for the measuring the oral temperature of baby or little child. Therefore, our TM-03 is molded as a pacifier. The patient contact portion is the thermometer's nipple which is made of medical silicon rubber. The body of TM-03 is then manufactured by ABS hard plastic. TM-03 utilizes the phenomenon of thermal conductivity changes of our selected NTC thermistor when there are changes of external environment temperature. Whenever the external temperature changed, the resistance of our thermistor changed uniformly. Then, the changes in resistance are converted to the changes of frequency of R-C oscillator circuit. This means TM-03 keep monitoring the frequency of the oscillator and the temperature can be measured accurately.
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