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    K Number
    K152640
    Device Name
    Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
    Manufacturer
    FUDAKANG INDUSTRIES CO., LTD
    Date Cleared
    2016-03-28

    (195 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Infrared Thermometer (FT-F11-BT) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

    Infrared Thermometers (FT-F21-BT, FT-F41-BT) are intended for intermittent measurement of human body temperature in people of all ages.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) summary for an Infrared Thermometer. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory clearance letter and the "Indications for Use" statement, not a scientific study report.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the requested information is not present in the provided document.

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