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510(k) Data Aggregation

    K Number
    K071028
    Device Name
    VIEWMATE SYSTEM
    Manufacturer
    EP MEDSYSTEMS
    Date Cleared
    2007-05-01

    (20 days)

    Product Code
    ITN, ITX, IYO
    Regulation Number
    890.3675
    Why did this record match?
    Product Code :

    ITN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
    Device Description
    The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System illustrated in Figure 1 is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex™ ultrasound catheter.
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    K Number
    K032669
    Device Name
    Y.E.S. POWERED WHEELCHAIR, MODEL T200
    Manufacturer
    YEOU EIR SHUEN MACHINERY CO., LTD.
    Date Cleared
    2003-11-12

    (76 days)

    Product Code
    ITN, ITI
    Regulation Number
    890.3675
    Why did this record match?
    Product Code :

    ITN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Y.E.S. Powered Wheelchair, T200
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