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510(k) Data Aggregation
K Number
K033283Device Name
CENTRA VIEW DEVICE LINK SYSTEM
Manufacturer
ICU DATASYSTEMS, INC.
Date Cleared
2003-10-27
(13 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
ICU DATASYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Centra View patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and pediatric patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices. Centra View is not intended for monitoring purposes, nor is it intended to control any of the independent bedside devices it is connected to.
The CentraView System:
- Is intended for use on neonatal, pediatric and adult patients.
- Is intended for use in critical care environments by trained healthcare providers.
- Does not require direct patient contact.
- Is a prescription device which restricts its sale and/or use except by the order of a physician.
Device Description
The Centra View ™ Device Link System receives digital data produced by external devices through device specific cables, and displays and stores this information for review by health care professionals. When connected to a bedside device, the Centra View™ Device Link System is intended for electronic data collection and clinical information management. Centra View ™ Device Link System is neither patient connected, nor does it remotely control the attached source device.
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