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510(k) Data Aggregation

    K Number
    K071019
    Device Name
    DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
    Manufacturer
    MESURE TECHNOLOGY CO.,LTD.
    Date Cleared
    2007-04-27

    (17 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 :

    DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES

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

    The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

    Device Description

    Digital Clinical Thermometer, Models ST8C Series

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Digital Clinical Thermometer. It does not contain information about acceptance criteria for a device's performance, a study proving it meets those criteria, or any details related to AI algorithms, ground truth, expert reviews, or sample sizes for testing or training sets.

    Therefore, I cannot provide the requested information based on the input. The document merely states that the device is substantially equivalent to legally marketed predicate devices.

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