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

    KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    K Number: K102609 · Decision Dec 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    K Number
    K102609
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andon Medical Co., Ltd.
    Date Received
    September 10, 2010
    Decision Date
    December 9, 2010
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Andon Medical Co., Ltd.

    K Number Device Name
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    K110017 AG-608N BLOOD GLUCOSE MONITORING SYSTEM
    K112738 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
    K102678 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
    K101307 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
    K093755 AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K093262 AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM