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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 K203435
Device Name Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
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 Number870.1025
Classification Product Code
MHX  
Date Received11/23/2020
Decision Date 07/16/2021
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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