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

    Bluetooth blood pressure monitor

    K Number: K182018 · Decision Oct 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    Bluetooth blood pressure monitor
    K Number
    K182018
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Kingyield Technology Co., Ltd.
    Date Received
    July 27, 2018
    Decision Date
    October 6, 2018
    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 Shenzhen Kingyield Technology Co., Ltd.

    K Number Device Name
    K161530 Bluetooth blood pressure monitor
    K123801 FINGER PULSE OXIMETER
    K112042 KINGYIELD WRIST BLOOD PRESSURE MONITOR
    K083043 KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201