Cleared Traditional

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

K203435 · Nihon Kohden Corporation · Cardiovascular
Jul 2021
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K203435 is an FDA 510(k) clearance for the Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 16, 2021, 235 days after receiving the submission on November 23, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K203435 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2020
Decision Date July 16, 2021
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 418
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
K252726 · Philips Medizin Systeme Boeblingen GmbH · Feb 2026
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · Philips Medizin Systeme Boeblingen GmbH · Oct 2025
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025

More from Nihon Kohden Corporation

View all
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
K251366 · OLT · Oct 2025
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
K243956 · CCK · Jun 2025
CNS-2101 Central Monitor
K223567 · MSX · Jul 2023
Life Scope PT BSM-1700 Series Bedside Monitor
K220976 · KOI · Jul 2022
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
K213316 · KOI · Dec 2021