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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Non-Contact Infrared Thermometer, model HL710H

    K Number: K211744 · Decision Nov 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    60
    Review Days
    170

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    Basic Information

    Device Name
    Non-Contact Infrared Thermometer, model HL710H
    K Number
    K211744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health & Life Co., Ltd.
    Date Received
    June 7, 2021
    Decision Date
    November 24, 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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