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510(k) Data Aggregation

    K Number
    K072635
    Device Name
    CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1
    Date Cleared
    2008-01-17

    (121 days)

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

    NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518 and Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.
    Device Description
    The applicant device of Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1 are the electronic thermometers by using a the temperature sensor. tor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC), JA31106, the CMOS digital clinical thermometer IC for measuring body temperature from 32.0℃~42.0℃(90°F ~ 109.0°F) All variants follow same design, same application with same performance and safety. The only difference is appearance. Therefore, all variants have same specifications parameters, same PCB Design, and same components with exception of shell. No antimicrobial or antithrombotic ingredient is applied on the applicant device. No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device. No specific drug or biologic is applied with the applicant device.
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