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510(k) Data Aggregation
K Number
K112047Device Name
AMCOM COMMTECH MESSENGER
Manufacturer
AMCOM SOFTWARE,INC.
Date Cleared
2011-09-13
(57 days)
Product Code
MSX
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AMCOM SOFTWARE,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Amcom™ Commtech Messenger™ (Messenger) 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, Messenger is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Messenger does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.
Messenger is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.
Device Description
Amcom™ Commtech Messenger™ (Messenger) is an intelligent software medical device, also called middleware, which forwards critical information from medical devices to the user via display devices provided by Amcom or third-party device companies. It creates an enterprise-wide hub for the management, prioritization, and response to key events. This includes the ability to send messages to the right people based on filtering and rules set up in the hospital, including escalated communications whenever necessary.
The ability of medical devices such as patient monitors (including telemetry), infusion pumps, and ventilators to provide real-time notifications of a change in condition is invaluable. These systems check physiological conditions and are linked to the patient via hard wire or wireless telemetry, depending on the patient's mobility. Getting notifications to medical staff who can take fast action not only increases patient safety, but can also save lives. Messenger allows users to be aware of their patients' status and alarm conditions when they are away from the patient and the medical devices associated with that patient.
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