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510(k) Data Aggregation

    K Number
    K102718
    Device Name
    DIGITAL THERMOMETER; DIGITAL THERMOMETER
    Manufacturer
    INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)
    Date Cleared
    2010-12-13

    (83 days)

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

    INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
    Device Description
    The GF-MT501 and GF-MT502 digital thermometer comprise 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. The thermometers use 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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