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510(k) Data Aggregation
K Number
K130234Device Name
NUVON VITALS CHARTING SYSTEM
Manufacturer
Date Cleared
2013-03-13
(42 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
NUVON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nuvon Vitals Charting System is an accessory to the Nuvon VEGA System (K103125) and is intended to display patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology. The Nuvon Vitals Charting System is only intended to display physiologic and other patient information and intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitored devices from which it obtains its data. The Nuvon Vitals Charting System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
Device Description
The Nuvon Vitals Charting System is a software only system that permits the display of data from biomedical, patient care devices, and ancillary hospital systems (e.g.: laboratory and hospital admission, discharge and transfer systems). The system can be used to review and validate the data for transfer to existing hospital information technology and electronic medical record systems. Additionally, the system can be used for patient surveillance to evaluate trends in patient data.
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K Number
K102135Device Name
VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM
Manufacturer
Date Cleared
2010-10-22
(85 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
NUVON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vector Event Grid Architecture System is intended for use in data collection from bedside and point of care biomedical devices and clinical information management systems either directly or through networks with independent bedside devices. The Vector Event Grid Architecture System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
Device Description
The VEGA System permits the transfer of data from biomedical and patient care devices to existing hospital information technology and electronic medical record systems. The VEGA System connects directly to biomedical devices and aggregates the data from multiple biomedical devices for transmission to electronic medical record systems. The VEGA System may also translate native biomedical device data into the HL7 standard as necessary.
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