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

    WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.

    K Number: K063542 · Decision Apr 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    137

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    Basic Information

    Device Name
    WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
    K Number
    K063542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesure Technology Co., Ltd.
    Date Received
    November 24, 2006
    Decision Date
    April 10, 2007
    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 Mesure Technology Co., Ltd.

    K Number Device Name
    K080981 EAR THERMOMETER, MODELS ST66 AND ST67
    K071019 DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
    K050303 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
    K042627 EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
    K042013 DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
    K023956 THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
    K041056 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88