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510(k) Data Aggregation

    K Number
    K202687
    Device Name
    Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
    Manufacturer
    Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.
    Date Cleared
    2021-02-18

    (156 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K191251
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Infrared Forehead Thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

    Device Description

    The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of degree C or degree F. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.

    AI/ML Overview

    Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:

    Device: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document refers to compliance with performance standards rather than explicitly listing acceptance criteria with numeric targets for all aspects. However, based on the discussions and the standards invoked, we can infer some key performance criteria.

    Acceptance Criteria CategorySpecific Criteria (Target/Standard)Reported Device Performance
    Measurement Accuracy±0.3°C (±0.5°F) within 34.043°C (93.2109.4°F), ±0.4°C (±0.7°F) within 32.033.9°C (89.693.0°F) (as per IEC 80601-2-56 and ASTM E1965)The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965 for measuring accuracy.
    Measuring Range32-43°C/89.6-109.4°F (as per IEC 80601-2-56)The performance testing shows that the subject device complies with performance standard IEC 80601-2-56.
    Measurement DistanceAbility to measure accurately within 0-5 cm (as per IEC 80601-2-56 and ASTM E1965)The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965.
    Operating ConditionFunctionality within 5°C40°C, Relative Humidity 2490% (as per IEC 80601-2-56 and ASTM E1965)The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965.
    Storage/Transport ConditionFunctionality within -20°C~+55°C, Relative Humidity
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