BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

    K Number: K203332 · Decision Feb 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
    K Number
    K203332
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hetaida Technology Co., Ltd.
    Date Received
    November 12, 2020
    Decision Date
    February 25, 2021
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Hetaida Technology Co., Ltd.

    K Number Device Name
    K243661 Electronic Blood Pressure Monitor
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    K200159 Non-contact Infrared Body Thermometer, model:HTD8823US
    K180387 Infrared Ear Thermometer
    K171888 Non-contact infrared body thermometer
    K180385 Infrared Body Thermometer