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510(k) Data Aggregation

    K Number
    K043286
    Device Name
    ANEROID SPHYGMOMANOMETER, MODEL BK2002
    Manufacturer
    WENZHOU BOKANG INSTRUMENT CO.,LTD
    Date Cleared
    2005-01-13

    (48 days)

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

    WENZHOU BOKANG INSTRUMENT 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 home for the measurement of systolic and diastolic pressure on adults. 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
    The device comproses tubing attached to a soft ineastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive sphygmomaniometer.
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