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

    DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER

    K Number: K132140 · Decision Feb 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    208

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    Basic Information

    Device Name
    DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
    K Number
    K132140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Duteck Industrial Co., Ltd.
    Date Received
    July 11, 2013
    Decision Date
    February 4, 2014
    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 Duteck Industrial Co., Ltd.

    K Number Device Name
    K060642 DUTECK BODY COMPOSITION ANALYZER
    K021601 MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
    K992327 DUTECK DIGITAL CLINICAL THERMOMETER