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510(k) Data Aggregation

    K Number
    K131771
    Device Name
    CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
    Manufacturer
    THERMOMEDICS INC.
    Date Cleared
    2013-10-07

    (112 days)

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

    THERMOMEDICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Caregiver professional Clinical Thermometer is an infrared thermometer intended for the measurement of human body temperature in people of all ages without contact to the body and may be used by medical professionals or by consumers in a home environment.
    Device Description
    Caregiver Professional Clinical Thermometer (Model PRO-TF300) is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
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