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510(k) Data Aggregation

    K Number
    K112282
    Device Name
    M VISUM ALERT ALARM MANAGEMENT SYSTEM
    Manufacturer
    Date Cleared
    2011-11-04

    (87 days)

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

    MVISUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The mVisum Alert Alarm Management System is software intended for use to display status and alarm events from other medical devices and patient information systems and associated physiological and other patient information. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm and physiological information to mobile healthcare providers. The mVisum Alert Alarm Management System is limited to use by qualified medical professionals who have been trained on the use of the system. It is intended to supplement and not to replace any part of the current patient monitoring systems. It is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
    Device Description
    The mVisum Alert Alarm Management System is a software based secondary alarm notification system that transmits alarms, text and physiological waveform data from patient monitoring devices to a graphical display. This could be either on a PC or on a mobile device carried by a trained professional in a hospital environment. It is also capable of transmitting alarms and physiological waveforms to clinician smartphones that operate on the cell phone data network. The system receives alarm conditions from patient monitoring networks through industry standard HL-7 or XML formats and transmits the notification including any waveform data to the client software component. The client software component can then display the text and the physiological waveform information to the clinician. The mVisum system only reads alarm information and does not change it or modify it in any way. It does not diagnose alarms but transmits what the Patient Monitoring System determines to be an alarm.
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