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510(k) Data Aggregation

    K Number
    K203454
    Device Name
    Infrared Thermometer
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd.
    Date Cleared
    2021-04-29

    (157 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Zhushi Pharmaceutical Group Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
    Device Description
    The Infrared Thermometer, Model ZST-A is a non-contact long-distance infrared thermometer which is specialized in measuring human body temperature. It contains buzzer prompt, memory reading, backlight reminder, temperature offset setting, alarm threshold setting, automatic shutdown and common functions of equipment. The Infrared Thermometer measures the temperature by using the principle of receiving infrared. The product is composed of built-in infrared detector and related hardware and software, which can receive, analyze and record the measured object and ambient temperature. Therefore, once the user approaches the specific part of the human body (forehead) and presses the measurement key, the infrared sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the passive infrared sensor, so as to accurately measure the body temperature of the human body. The measurement distance of the subject device is 1~5 cm from the middle of the forehead.
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