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

    Infrared Thermometer, Model: HW-1

    K Number: K211583 · Decision Sep 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    102

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    Basic Information

    Device Name
    Infrared Thermometer, Model: HW-1
    K Number
    K211583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dongguan Simzo Electronic Technology Co., Ltd.
    Date Received
    May 24, 2021
    Decision Date
    September 3, 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 Dongguan Simzo Electronic Technology Co., Ltd.

    K Number Device Name
    K230379 Portable (Ultrasonic) Nebulizer
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