Next Generation NetKonnect

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Nihon Kohden Digital Health Solutions, Inc.

The following data is part of a premarket notification filed by Nihon Kohden Digital Health Solutions, Inc. with the FDA for Next Generation Netkonnect.

Pre-market Notification Details

Device IDK220989
510k NumberK220989
Device Name:Next Generation NetKonnect
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Nihon Kohden Digital Health Solutions, Inc. 14 Bunsen Irvine,  CA  92618
ContactMaria Pronina
CorrespondentMaria Pronina
Nihon Kohden Digital Health Solutions, Inc. 14 Bunsen Irvine,  CA  92618
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-07-29

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