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510(k) Data Aggregation

    K Number
    K170466
    Device Name
    Automatic Blood Pressure Monitor Model LD-518 & LD-537
    Manufacturer
    Honsun(Nantong) Co., Ltd.
    Date Cleared
    2017-10-27

    (254 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Honsun(Nantong) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scian Automatic Digital Blood Pressure Monitor, Models LD-518 & LD-537, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.
    Device Description
    Not Found
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    K Number
    K170454
    Device Name
    Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
    Manufacturer
    Honsun(Nantong) Co., Ltd.
    Date Cleared
    2017-10-25

    (252 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Honsun(Nantong) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.
    Device Description
    Not Found
    Ask a Question

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