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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K220989
Device Name Next Generation NetKonnect
Applicant
Nihon Kohden Digital Health Solutions, Inc.
14 Bunsen
Irvine,  CA  92618
Applicant Contact Maria Pronina
Correspondent
Nihon Kohden Digital Health Solutions, Inc.
14 Bunsen
Irvine,  CA  92618
Correspondent Contact Maria Pronina
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/04/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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