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

    CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER

    K Number: K070578 · Decision Jul 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    132

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    Basic Information

    Device Name
    CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER
    K Number
    K070578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zen Strong Medical Technology Co., Ltd.
    Date Received
    March 1, 2007
    Decision Date
    July 11, 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 Zen Strong Medical Technology Co., Ltd.

    K Number Device Name
    K090027 BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107
    K070473 BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX