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510(k) Data Aggregation

    K Number
    K193043
    Device Name
    Critical Alert CommonPath Enterprise
    Manufacturer
    Date Cleared
    2020-05-11

    (193 days)

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

    Critical Alert

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of Critical Alert CommonPath Enterprise is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s). For medical, near real time alarms, Critical Alert CommonPath Enterprise is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Critical Alert CommonPath Enterprise does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert. Critical Alert CommonPath Enterprise is intended for use as a secondary alert. It does not replace the alarm function on the primary device.
    Device Description
    Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies. Critical Alert CommonPath Enterprise is intended for use as a secondary alarm; it does not replace the alarm function on the primary device. Users receive interactive, time-critical information from clinical systems directly via their display devices as text (visual) or alarms (audible) or data. Received attributes related to the presentation of alerts include text and tones (beeps) in addition to and in coordination with event priorities. CommonPath allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system. CommonPath connects to the information sources through wired ethernet connections which are part of the customer's infrastructure and acquires patient data from clinical systems. The user configures CommonPath to determine which information, including alarm notifications, is delivered to which users. CommonPath then formats the data for wireless delivery to the display devices through a messaging server.
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