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510(k) Data Aggregation

    K Number
    K193387
    Device Name
    Arm Electronic Sphygmomanometer
    Date Cleared
    2021-01-27

    (418 days)

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

    ShenZhen Changkun Technology CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Arm Electronic Sphygmomanometer is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.
    Device Description
    The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.
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