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

    MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER

    K Number: K021601 · Decision Jul 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    56

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    Basic Information

    Device Name
    MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
    K Number
    K021601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Duteck Industrial Co., Ltd.
    Date Received
    May 15, 2002
    Decision Date
    July 10, 2002
    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
    K132140 DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
    K060642 DUTECK BODY COMPOSITION ANALYZER
    K992327 DUTECK DIGITAL CLINICAL THERMOMETER