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510(k) Data Aggregation

    K Number
    K190902
    Device Name
    RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
    Manufacturer
    Wenzhou Renhua Instruments Co., Ltd
    Date Cleared
    2019-05-22

    (44 days)

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

    Wenzhou Renhua Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RH non-Automated Blood Pressure Meter 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 be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory. depending on the model.
    Device Description
    RH non-Automated Blood Pressure Meter 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 Max02, Max0201, Max0202, Max0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model Max0202, Max0203 include additional Stethoscope (Single head, Dual head and Sprague Rappaport). It is conjunction with Stethoscope when use. The PVC or nature latex inflation bulb and optional various size of cuffs which cuffs outside layer is made of Nylon Cloth or Cotton Cloth can be selected according to user's need.
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