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510(k) Data Aggregation
K Number
K130339Device Name
CLINICAL ALERT NOTIFICATION
Manufacturer
EXTENSION , INC
Date Cleared
2013-07-11
(150 days)
Product Code
MSX
Regulation Number
870.2300Why 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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