BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ELECTRONIC THERMOMETER

    K Number: K131210 · Decision Mar 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    323

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    Basic Information

    Device Name
    ELECTRONIC THERMOMETER
    K Number
    K131210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Pump Medical System Co., Ltd.
    Date Received
    April 29, 2013
    Decision Date
    March 18, 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 Shenzhen Pump Medical System Co., Ltd.

    K Number Device Name
    K161712 Arm automatic blood pressure monitor
    K161708 Arm automatic blood pressure monitor
    K151258 Arm automatic blood pressure monitor
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    K141416 BLOOD PRESSURE MONITOR
    K130325 ARM AUTOMATIC BLOOD PRESSURE MONITOR