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

    IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081

    K Number: K100488 · Decision Jul 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    25
    Review Days
    153

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    Basic Information

    Device Name
    IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
    K Number
    K100488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    February 19, 2010
    Decision Date
    July 22, 2010
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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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