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510(k) Data Aggregation

    K Number
    K192500
    Device Name
    Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
    Manufacturer
    Honsun(Nantong)Co.,Ltd
    Date Cleared
    2020-04-06

    (207 days)

    Product Code
    DXQ, LDE
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Honsun(Nantong)Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
    Device Description
    Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.
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    K Number
    K170866
    Device Name
    Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
    Manufacturer
    Honsun(Nantong)Co.,Ltd
    Date Cleared
    2018-02-21

    (335 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 LD-576, LD-579 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.
    Device Description
    Scian Automatic Digital Blood Pressure Monitor, Model LD-575, LD-576 and LD-579
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