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510(k) Data Aggregation

    K Number
    K170662
    Device Name
    Non Contact Infrared Forehead Thermometer
    Manufacturer
    Intrinity Global Limited
    Date Cleared
    2017-11-22

    (264 days)

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

    Intrinity Global Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
    Device Description
    The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed near the body and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat. The thermometer includes two models: TVT-200, TVT-200 PLUS. The TVT-200 model includes four colors: pink, grey, orange and purple. While TVT-200 PLUS has only orange color. The Non Contact Infrared Forehead Thermometer is composed by an IR sensor, a Human temperature measurement button, an object temperature button, Battery compartment, Buzzer, °C /°F button, a LCD and an enclosure. The functions of TVT-200 and TVT-200 PLUS are the same, except the Back Light.
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