BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INFRARED EAR THEROMETER

    K Number: K111703 · Decision Mar 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    286

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    Basic Information

    Device Name
    INFRARED EAR THEROMETER
    K Number
    K111703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fudakang Industrial Co., Ltd.
    Date Received
    June 17, 2011
    Decision Date
    March 29, 2012
    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 Fudakang Industrial Co., Ltd.

    K Number Device Name
    K172121 Digital Thermometer
    K160308 Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
    K150430 Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor