Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System

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

Nihon Kohden Corporation

The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System.

Pre-market Notification Details

Device IDK203435
510k NumberK203435
Device Name:Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo,  JP 161-8560
ContactSandra Gadeyne
CorrespondentSandra Gadeyne
Nihon Kohden America 15353 Barranca Pkwy Irvine,  CA  92618
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-07-16

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