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510(k) Data Aggregation

    K Number
    K130339
    Device Name
    CLINICAL ALERT NOTIFICATION
    Manufacturer
    EXTENSION , INC
    Date Cleared
    2013-07-11

    (150 days)

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

    EXTENSION , INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is important to patient care, nursing vigilance and overall hospital operations. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about critical patient alarms by drawing an identified individual's attention to a defined patient in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification solution is not intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical on solution. The EXTENSION Clinical Alert Notification solution is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type acute care environments and is not for home use.
    Device Description
    The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers. The EXTENSION Clinicalion solution alerts and informs the clinician about patient alarms. The EXTENSION Inc. device is not intended to replace any part of the patient monitoring system or patient monitoring procedures already existing for the medical devices interfaced with the EXTENSION Clinical Alert Notification solution. The EXTENSION Clinical Alert Notification solution is made up of standard telecommunications and information technology. EXTENSION develops the application software that runs on a virtual machine and is accessed by client devices (PC computers running web browsers, wireless voice over IP phone handsets). The EXTENSION Clinical Alert Notification solutions and transmits data similarly to the predicate devices. The EXTENSION Clinical Alert Notification solution and predicate devices use similar data transmission and communications technologies.
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