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510(k) Data Aggregation

    K Number
    K230859
    Device Name
    Aneroid Sphygmomanometer
    Manufacturer
    Wenzhou Kangshun Medical Devices Co.,Ltd
    Date Cleared
    2023-06-28

    (91 days)

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

    Wenzhou Kangshun Medical Devices Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aneroid sphygmomanometer is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
    Device Description
    The product is 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 of MODEL Ks-1222,Ks-1621,Ks-3201,Ks-2203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. It is conjunction with Stethoscope when use.
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