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510(k) Data Aggregation

    K Number
    K161728
    Device Name
    Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
    Manufacturer
    MICROFILE INTELLECTUAL PROPERTY GMBH
    Date Cleared
    2016-12-05

    (166 days)

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

    MICROFILE INTELLECTUAL PROPERTY GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
    Device Description
    The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the forehead. Microlife FR1MN1-1 especially enables the user to take measurements and be alerted for possible elevated temperature readings accordingly. The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1, consists of mainly seven parts: a) Thermopile Sensor b) Application-Specific Intergrated Circuit c) Erasable Programmable Read-Only Memory Integrated Circuit d) Lens e) LCD and Backlight f) 2 Keys (Start key, O/I key) g) 2 batteries AAA (LR03) 1.5V The new Model FR1MN1-1 has the same intended use and temperature measurement fundamental algorithm as the 510(k) cleared devices. Auto-Display memory The last reading is automatically displayed for 2 seconds when the unit is switched ON.
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