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510(k) Data Aggregation
K Number
K172966Device Name
CMS-2000 Central Monitoring System
Manufacturer
Date Cleared
2017-12-08
(73 days)
Product Code
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
Advanced Instumentations, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CMS-2000 Central Monitoring System provides centralized monitoring and critical care management for patients monitored by bedside monitors. From the CMS-2000, clinicians can gain access to patient information for patients on the Network. The CMS-2000 displays waveforms, parameters and alarm status of bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.
Device Description
The CMS-2000 Central Monitoring System is a software production, which runs on a PC platform running under the Microsoft Windows XP or Windows 7 operating system. Through specified protocol, one CMS-2000 can connect with multi-monitors from ADVANCED INSTRUMENTATIONS to collect patients' information and monitoring data such as physiological waveforms, physiological parameters and alarms. The CMS-2000 can also send bidirectional control instruction to bedside monitors to change patients' information, alarm limits and conduct NIBP measurements. The bedside Patient Physiological Monitors have been cleared by the FDA under K123048 separately. The monitoring information collected by the CMS-2000 can be saved and printed. At the same time, the old records can be searched conveniently and quickly.
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