Nihon Kohden Corporation
Medical device manufacturer in Tokyo, JP.
31510(k) clearances
0PMA approvals
0recalls
Device types
- MHX Monitor, Physiological, Patient(With… 6
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 6
- GWQ Full-Montage Standard Electroencephalograph 3
- KOI Stimulator, Nerve, Peripheral, Electric 3
- GWF Stimulator, Electrical, Evoked Response 2
- OMA Amplitude-Integrated Electroencephalograph 2
- DRG Transmitters And Receivers, Physiological… 1
- GYC Electrode, Cortical 1
- DSI Detector And Alarm, Arrhythmia 1
- OMC Reduced- Montage Standard Electroencephalogr… 1
- MWI Monitor, Physiological, Patient (Without… 1
- GYB Media, Electroconductive 1
- MSX System, Network And Communication… 1
- OLT Non-Normalizing Quantitative… 1
- DXQ Blood Pressure Cuff 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | 08/12/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | 05/06/2026SE |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…OLT · Traditional | 10/09/2025SE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | 06/10/2025SE |
| K223567 | CNS-2101 Central MonitorMSX · Traditional | 07/31/2023SE |
| K220976 | Life Scope PT BSM-1700 Series Bedside MonitorKOI · Special | 07/21/2022SE |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…KOI · Special | 12/29/2021SE |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside…MHX · Traditional | 07/16/2021SE |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…KOI · Traditional | 05/02/2021SE |
| K191975 | Elefix V Paste for EEG & EMGGYB · Traditional | 02/07/2020SE |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs MonitorMWI · Traditional | 05/28/2019SE |
| K183529 | AE-120A EEG Head SetOMC · Traditional | 03/19/2019SE |
| K171765 | Nihon Kohden CO2 MonitorCCK · Traditional | 10/11/2017SE |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200GWQ · Traditional | 08/25/2017SE |
| K163644 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | 05/19/2017SE |
| K163459 | Nihon Kohden Vital Sign TelemeterMHX · Traditional | 04/04/2017SE |
| K161860 | TG-970P CO2 Sensor KitCCK · Traditional | 02/24/2017SE |
| K153707 | Nihon Kohden Vital Sign TelemeterMHX · Traditional | 09/02/2016SE |
| K152305 | Nihon Kohden Afib Detection Program QP-039PDSI · Abbreviated | 04/08/2016SE |
| K151080 | Nihon Kohden CSM 1901 Bedside MonitorMHX · Traditional | 11/05/2015SE |
| K142624 | Neuromaster G1 MEE200GWF · Traditional | 04/24/2015SE |
| K130238 | Nihon Kohden AE-918P Neuro UnitOMA · Traditional | 03/04/2015SE |
| K122214 | TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)CCK · Traditional | 05/21/2013SE |
| K120888 | PSG-1100 Sleep Diagnostic SystemGWQ · Special | 11/09/2012SE |
| K120397 | MEB-2300A Neuropack Evoked Potential and Emg Measuring SystemGWF · Traditional | 09/19/2012SE |
| K112637 | Netkonnect Remote Network ExtensionMHX · Special | 12/09/2011SE |
| K110594 | GF-210R Multi-Gas Module for Nohon Kohden Bedside MonitorsCCK · Traditional | 10/28/2011SE |
| K110410 | MS-120BK Electric Stimulator (Extension Unit)GYC · Traditional | 08/04/2011SE |
| K110376 | PE-210AK Switch BoxGWQ · Traditional | 07/29/2011SE |
| K102106 | Nihon Khden Prefense EDNS-9000 Series Central Nurse StationDRG · Traditional | 12/17/2010SE |
| K102376 | Nihon Kohden CNS-6200 Series Central Nurse Station, Model CNS-6201MHX · Special | 12/07/2010SE |