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510(k) Data Aggregation

    K Number
    K101043
    Device Name
    ECT DIGITAL THERMOMETER
    Manufacturer
    CHANGSHAN ESTAR ELECTRONICS CO., LTD.
    Date Cleared
    2010-07-21

    (98 days)

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

    CHANGSHAN ESTAR ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.
    Device Description
    The ECT digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This thermometer uses a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' ▼' in LCD display.
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