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510(k) Data Aggregation

    K Number
    K023510
    Device Name
    TRUTEK SELECT MODEL TT-1001
    Manufacturer
    TRUTEK, INC.
    Date Cleared
    2003-02-04

    (106 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TruTek Select Model TT-1001 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal. It is intended for use by the medical professional on the adult and pediatric patient.

    Device Description

    The TruTek Select Model TT-1001 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the TruTek Select Model TT-1001 Thermometer. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter primarily addresses the regulatory approval of the device based on its substantial equivalence.

    Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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