Company ยท JP
Nihon Kohden Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 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 Signal, Radiofrequency | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 |
| DXQ | Blood Pressure Cuff | 1 |
| GYB | Media, Electroconductive | 1 |
| GYC | Electrode, Cortical | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 |
| OMC | Reduced- Montage Standard Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 2026 | K251641 | GF-310R Multigas Unit (GF-310R) Nihon Kohden Corporation, JP | CCK |
| May 6, 2026 | K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff Nihon Kohden Corporation, JP | DXQ |
| Oct 9, 2025 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) Nihon Kohden Corporation, JP | OLT |
| Jun 10, 2025 | K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) Nihon Kohden Corporation, JP | CCK |
| Jul 31, 2023 | K223567 | CNS-2101 Central Monitor Nihon Kohden Corporation, JP | MSX |
| Jul 21, 2022 | K220976 | Life Scope PT BSM-1700 Series Bedside Monitor Nihon Kohden Corporation, JP | KOI |
| Dec 29, 2021 | K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, N Nihon Kohden Corporation, JP | KOI |
| Jul 16, 2021 | K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System Nihon Kohden Corporation, JP | MHX |
| May 2, 2021 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series Nihon Kohden Corporation, JP | KOI |
| Feb 7, 2020 | K191975 | Elefix V Paste for EEG & EMG Nihon Kohden Corporation, JP | GYB |
| May 28, 2019 | K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor Nihon Kohden Corporation, JP | MWI |
| Mar 19, 2019 | K183529 | AE-120A EEG Head Set Nihon Kohden Corporation, JP | OMC |
| Oct 11, 2017 | K171765 | Nihon Kohden CO2 Monitor Nihon Kohden Corporation, JP | CCK |
| Aug 25, 2017 | K171124 | Nihon Kohden Wireless Input Unit WEE-1200 Nihon Kohden Corporation, JP | GWQ |
| May 19, 2017 | K163644 | Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation, JP | OMA |
| Apr 4, 2017 | K163459 | Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation, JP | MHX |
| Feb 24, 2017 | K161860 | TG-970P CO2 Sensor Kit Nihon Kohden Corporation, JP | CCK |
| Sep 2, 2016 | K153707 | Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation, JP | MHX |
| Apr 8, 2016 | K152305 | Nihon Kohden Afib Detection Program QP-039P Nihon Kohden Corporation, JP | DSI |
| Nov 5, 2015 | K151080 | Nihon Kohden CSM 1901 Bedside Monitor Nihon Kohden | MHX |
| Apr 24, 2015 | K142624 | Neuromaster G1 MEE200 Nihon Kohden Corporation, JP | GWF |
| Mar 4, 2015 | K130238 | NIHON KOHDEN AE-918P NEURO UNIT Nihon Kohden Corp. | OMA |
| May 21, 2013 | K122214 | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) Nihon Kohden Corp. | CCK |
| Nov 9, 2012 | K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM Nihon Kohden Corp. | GWQ |
| Sep 19, 2012 | K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM Nihon Kohden Corp. | GWF |
| Dec 9, 2011 | K112637 | NETKONNECT REMOTE NETWORK EXTENSION Nihon Kohden | MHX |
| Oct 28, 2011 | K110594 | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS Nihon Kohden Corp. | CCK |
| Aug 4, 2011 | K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) Nihon Kohden Corp. | GYC |
| Jul 29, 2011 | K110376 | PE-210AK SWITCH BOX Nihon Kohden Corp. | GWQ |
| Dec 17, 2010 | K102106 | NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION Nihon Kohden Corp. | DRG |
| Dec 7, 2010 | K102376 | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 Nihon Kohden Corp. | MHX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||