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510(k) Data Aggregation

    K Number
    K090564
    Device Name
    TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370
    Manufacturer
    TRULY INSTRUMENT LIMITED
    Date Cleared
    2009-06-24

    (114 days)

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

    TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

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

    The Truly TET-350 TET-370 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal , pediatric and adult population used in the home setting.

    Device Description

    Truly Infrared Ear Thermometer TET-350 TET-360 TET-370

    AI/ML Overview

    The provided document is a 510(k) summary for an Infrared Ear Thermometer. It does not contain a study report or detailed information about acceptance criteria and device performance based on a study.

    Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the device's classification, substantial equivalence to a predicate device, and regulatory approval. It does not include specific performance data or study details.

    To answer your request, a study report detailing performance metrics would be necessary.

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