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510(k) Data Aggregation

    K Number
    K040802
    Device Name
    HEMOSONIC 200HEMODYNAMIC MONITOR
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2004-04-28

    (30 days)

    Product Code
    DPN
    Regulation Number
    862.3700
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    Product Code :

    DPN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.
    Device Description
    The probe jacket contains the acoustic gel into which the ultrasound crystals are placed. It consists of a plug rod, tip cap, hub, body, acoustic gel and tip.
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