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510(k) Data Aggregation

    K Number
    K962369
    Device Name
    TALKING DIGITAL THERMOMETER
    Manufacturer
    ULTMOST INDUSTRIAL CORP.
    Date Cleared
    1996-08-20

    (62 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K935466,K902624,K903590
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found.

    Device Description

    Talking Digital Thermometer

    AI/ML Overview

    The provided document is a 510(k) summary for a Talking Digital Thermometer, dating back to 1996. It describes the device, its classification, and predicate devices.

    However, the document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement. These are typically found in the clinical testing or performance validation sections of a 510(k) submission, which are not present in this summary.

    Therefore, I cannot fulfill your request for the specific information you've outlined, as it is not provided in the input text. The document is a high-level summary that serves as an introduction to the device for regulatory purposes.

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