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

    Infrared Ear Thermometer

    K Number: K180387 · Decision Jan 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    332

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    Basic Information

    Device Name
    Infrared Ear Thermometer
    K Number
    K180387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hetaida Technology Co., Ltd.
    Date Received
    February 12, 2018
    Decision Date
    January 10, 2019
    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
    K241202 Electric nasal aspirator (HTD2601US)
    K223170 Electronic Blood Pressure Monitor, model: HTD6602US
    K203332 Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
    K200159 Non-contact Infrared Body Thermometer, model:HTD8823US
    K171888 Non-contact infrared body thermometer
    K180385 Infrared Body Thermometer