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510(k) Data Aggregation

    K Number
    K142106
    Device Name
    DECISIO HEALTH PATIENT DASHBOARD
    Manufacturer
    DECISIO HEALTH, INC.
    Date Cleared
    2015-01-18

    (170 days)

    Product Code
    MWI, MON
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DECISIO HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Decisio Health Patient Dashboard is a decision support device indicated for aggregating, displaying, and managing physiologic and other patient information. This information is generated by third party medical devices and patient information systems. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities. The Decisio Health Patient Dashboard is intended for use by clinicians in healthcare facilities.
    Device Description
    The Decisio Health Patient Dashboard ("Patient Dashboard") is a data aggregation and visualization software device. The Patient Dashboard is designed to display patient information, facility specific care protocols, and visual cues to care providers on a single display device. The Patient Dashboard is configured to receive patient data through the facility's Electronic Medical Record system and display information to the user on a patient monitor, computer, or a mobile device. Data received through the EMR includes input from various sources within the hospital, including manually entered data into the EMR (e.g., laboratory data), vital signs monitors, ventilators, IV pumps, and Foley catheter devices. The data the Patient Dashboard receives are then stored, filtered, and displayed through the Patient Dashboard web browser application. The Patient Dashboard is customized to individual facility's care as it is programmed with the facility's treatment protocols, which dictate the information that is displayed relative to those protocols. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.
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