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510(k) Data Aggregation

    K Number
    K210171
    Device Name
    Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
    Manufacturer
    Sichuan YOUKEDE Medical Equipment Co.,Ltd
    Date Cleared
    2022-03-18

    (420 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202420
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.

    Device Description

    The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from central forehead.

    The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of no-contact use and compensation of the temperature reading.

    The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries.

    The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701), based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Predicate)Reported Device Performance (Subject Device)Notes/Differences
    Measurement Range: 34°C ~ 43°CMeasurement Range: 34°C ~ 42°CDifferent, but stated to meet ISO 80601-2-56:2017/Amd.1:2018
    Accuracy:Accuracy:
    ±0.2°C: 35.0°C ~ 42.0°C±0.3°C: 34°C~42°CDifferent, but stated to meet ISO80601-2-56 and demonstrated through clinical trial
    ±0.3°C: 34.0°C ~ 34.9°C, 42.1°C ~ 43°C
    Response time: 1SResponse time:
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