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510(k) Data Aggregation

    K Number
    K063137
    Device Name
    PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
    Manufacturer
    Date Cleared
    2007-05-01

    (197 days)

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

    PHARMASMART, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PharmaSmart Models PS-1000, PS-1500 and PS-2000 are indicated for use for non-invasive oscillometric blood pressure and pulse rate monitoring by the general public in a sit down kiosk form. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.
    Device Description
    The PharmaSmart Blood Pressure kiosks Models PS-1000, PS-1500 and PS-2000 provide a self service means for measuring and tracking an individual's blood pressure (both diastolic and systolic) and pulse rate. The unattended kiosk can be installed in retail locations and is typically associated with pharmacy operations. Blood pressure readings are taken automatically by the customer with no operator assistance required. Readings are reported on the LCD display, printed on an optional thermal printer, or stored on an optional smart card for long term tracking. The PharmaSmart Blood Pressure kiosk provides a self-contained system for measuring and reporting blood pressure and pulse. The user interface consists of a simple membrane keypad with 3 buttons (4 buttons for some language translations) for user control, an LCD monitor for feedback, an automatically inflating blood pressure cuff to take readings and an optional thermal printer for hard copy output. The core functionality of the system is to take and record blood pressure readings. This is accomplished by the user with no assistance required. When seated at the kiosk the user's arm is comfortably inserted into the automatically inflating blood pressure cuff. When the reading is initiated using the membrane keyboard the cuff automatically inflates and deflates and records the systolic and diastolic blood pressure readings along with the user's pulse.
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