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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K223567
Device Name CNS-2101 Central Monitor
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Sandra Gadeyne
Correspondent
Nihon Kohden America
15353 Barranca Pkwy.
Irvine,  CA  92618
Correspondent Contact Sandra Gadeyne
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
DRQ   MHX   MWI  
Date Received11/29/2022
Decision Date 07/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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