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510(k) Data Aggregation

    K Number
    K101198
    Device Name
    CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
    Manufacturer
    COMPUTERIZED SCREENING, INC.
    Date Cleared
    2010-08-04

    (97 days)

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

    COMPUTERIZED SCREENING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CSI Model 9K Managed Health System Kiosk is an automated non invasive screening device intended for voluntary use by the general public. The device measures systolic and diastolic blood pressure, pulse and if optionally equipped, weight and temperature. Users may also manually enter or download blood glucose level. Data from the Model 9K may be stored by the user for tracking purposes. It is not a diagnostic device, and only furnishes data so users can consult their personal physicians.
    Device Description
    The CSI Model 9K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in corporate lobbies and can be part of corporate wellness programs to track changes over time. The device has a touch screen for user interface. The user may select from a menu of items. For instance, touching the button "Blood Pressure" on the touch screen will result in a sub menu that will direct the user to insert the arm in the cuff mechanism before pressing the "Start" button on the touch screen. The unit also consists of a "Release" push button that is separate from the touch screen. This "Release" button would result in the immediate deflation of the cuff and the aborting of the test. This well marked red button is meant for use in the event of an emergency. Other buttons on the main menu of the touch screen display would result in the user receiving the blood pressure (systolic and diastolic), heart rate, weight and temperature readings. In addition to measuring the user's blood pressure, weight and temperature, the 9K may also be capable of accepting uploaded data from a One Touch Ultra Glucometer and playing videos on health topics. Data measured by the 9K or input into the 9K can be stored for tracking purposes. The 9K may also have the ability to display websites like WebMD, MayoClinic and corporate portals. Videos may present medical information and present symptoms but not diagnoses. The 9K may also be equipped with a scanner, printer, finger print reader and signature pad.
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    K Number
    K093389
    Device Name
    CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
    Manufacturer
    COMPUTERIZED SCREENING, INC.
    Date Cleared
    2009-11-17

    (18 days)

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

    COMPUTERIZED SCREENING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.
    Device Description
    The CSI Model 5K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in retail establishments and drug stores and may or may not be part of the pharmacy. The device has push buttons for user interface. Such buttons include "Start" button to start the test after the user has inserted the arm into the cuff mechanism, a "Release" button to deflate the cuff mechanism in the event of an emergency, a "Weight" button to start the process of measuring the weight of the user. The output of the machine includes displays to indicate the blood pressure (systolic and diastolic), heart rate and weight. To start the process, the user inserts her arm into the cuff and pushes a button. The machine then proceeds to inflate the cuff and measure the blood pressure using oscillometric method. Once measured, the blood pressure (both systolic and diastolic) and the heart rate are output to the display mounted on the front of the device.
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