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510(k) Data Aggregation

    K Number
    K041646
    Device Name
    THERMOTEK Q5
    Manufacturer
    SAAT LTD.
    Date Cleared
    2004-07-22

    (35 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K010502,K935267,K881909
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.

    Device Description

    The device is an electronic contact thermometer. It consists of a commercial thermistor in a stainless steel cap, a tip and rigid plastic housing that contains a PCBA, a LCD and two flexible buttons (On and Mode). The device is operated on a single 3V Lithium battery. Thanks to its small size, the thermistor reaches a thermal equilibrium with the measured subject in about 5 seconds in a bath and in oral and rectal modes, and in about 20 sec in axial mode.

    AI/ML Overview

    This document is a 510(k) summary for the ThermoTek™ Q5 oral thermometer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document states that "The ThermoTek Q5 was tested in a series of safety and performance tests, showing its compliance with the relevant standards, without raising any safety and/or effectiveness issues." However, no details about these tests, the specific acceptance criteria, or the results are provided.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove they are met from the provided text.

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