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510(k) Data Aggregation

    K Number
    K023069
    Device Name
    TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER
    Manufacturer
    MEDPORT, INC.
    Date Cleared
    2002-10-18

    (32 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 Timex ACCU-CURVE and Traditional Digital Oral Thermometers are electronic thermometers to measure patient temperature orally. Targeted users include professional and over-the-counter users.

    Device Description

    Timex ACCU-CURVE Digital Oral Thermometer, Timex Oral Digital Thermometer

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Timex ACCU-CURVE Digital Oral Thermometer and Timex Oral Digital Thermometer. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

    However, this document does not contain information regarding detailed acceptance criteria or a study proving that the device meets specific performance criteria. The letter acknowledges a "Section 510(k) premarket notification" which would typically include such study information, but the study details themselves are not present in the provided text.

    Therefore, I cannot extract the requested information from this document. To fulfill your request, I would need access to the actual 510(k) submission document that details the performance studies conducted for these thermometers.

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