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510(k) Data Aggregation

    K Number
    K173246
    Device Name
    ANEROID SPHYGMOMANOMETER
    Manufacturer
    Wenzhou Bokang Instruments Co., Ltd
    Date Cleared
    2018-05-30

    (236 days)

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

    Wenzhou Bokang Instruments 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. 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 Sphgmomanometer, Models BK2002, BK2002-3001, BK2002a, BK2002a-3001, BK2015, BK2015-3001, 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 of MODEL BK2002-3001, BK2015, BK2015-3001 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model BK2002-3001 and BK2015-3001 include additional stethoscope. It is conjunction with Stethoscope when use.
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    K Number
    K111141
    Device Name
    BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    WENZHOU BOKANG INSTRUMENTS CO., LTD.
    Date Cleared
    2012-02-21

    (305 days)

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

    WENZHOU BOKANG INSTRUMENTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023 are non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate by using an inflating cuff which is wrapped around the upper arm or wrist. The device is indicated for use in adults only.
    Device Description
    Non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate for adults only. Model BK6001 is a semi-auto digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by a manual air pump. Model BK6002 is an automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated automatically by an electrical air pump. Model BK6023 is a wrist automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the wrists. The cuff is inflated automatically by a electrical air pump. The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled rapidly and automatically released by a electric valve at a constant rate after the measurement. The measurement results including diastolic, systolic pressure and heart pulse rate are displayed on the LCD. Besides the real-time display, the blood pressure and pulse values are also averaged, stored, and recalled from the last data.
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