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510(k) Data Aggregation

    K Number
    K090395

    Validate with FDA (Live)

    Device Name
    FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2009-03-10

    (21 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Special
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K113446
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FORA IR20b/FORA IR21b Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an ear thermometer. It does not contain information about acceptance criteria, device performance, study details (sample sizes, ground truth, experts), or MRMC studies. Therefore, I cannot extract the requested information from this document.

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