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

    WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

    K Number: K100226 · Decision Mar 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    52

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    Basic Information

    Device Name
    WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
    K Number
    K100226
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rio Flexon Technology Co., Ltd.
    Date Received
    January 25, 2010
    Decision Date
    March 18, 2010
    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 Rio Flexon Technology Co., Ltd.

    K Number Device Name
    K081256 WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
    K062445 MONITORING EAR THERMOMETER, MODEL BTM-D1A