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510(k) Data Aggregation
K Number
K220989Device Name
Next Generation NetKonnect
Manufacturer
Nihon Kohden Digital Health Solutions, Inc.
Date Cleared
2022-07-29
(116 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
Nihon Kohden Digital Health Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Next Generation NetKonnect is interface the Nihon Kohden monitoring network with networked client PCs to annunciate and display patient monitoring information to healthcare providers. The device is intended for use in near real-time monitoring of routing patient status and alarm events. Next Generation NetKonnect supplements the primary patient monitoring system by providing a forwarding for annunciating and displaying patient alarm events and event related information including vital signs values and waveforms. The system is intended for use on any patients as determined by qualified medical personnel within a hospital or clinical environment.
Device Description
NGNK is a software product that runs on Microsoft Windows architecture. NGNK will communicate with Nihon Kohden devices by a network connection and through the Gateway. The NGNK is intended to interface the Nihon Kohden monitoring network to annunciate and display patient monitoring information to healthcare providers. The device is intended for use in near real-time monitoring of patient status and alarm events. NGNK supplements the primary patient monitoring system by providing remote monitoring capability, including vital signs, alarms and waveforms.
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