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

    Infra-red forehead thermometer

    K Number: K160999 · Decision Aug 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    112

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    Basic Information

    Device Name
    Infra-red forehead thermometer
    K Number
    K160999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
    Date Received
    April 11, 2016
    Decision Date
    August 1, 2016
    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 Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

    K Number Device Name
    K172870 Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
    K172861 Digital thermometer(with disposable thermometer cover)