Data / Medical devices / Japan / Nihon Kohden Corp.
Nihon Kohden Corp.: FDA-registered device maker in SHINJUKU-KU Tokyo, Japan, 53 510(k) clearances
Nihon Kohden Corp. is registered with the FDA (registration 9611252) in SHINJUKU-KU Tokyo, Japan. It lists 48 device types. The FDA files 53 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611252
- FEI number
- 3002807720
- Address
- 31-4 Nishiochiai, 1-Chome, SHINJUKU-KU Tokyo, Japan, 161-8560
- Owner or operator
- NIHON KOHDEN CORP. (8030227)
- Roles
- Specification developer
- First device listed
- October 31, 2007
- Registered through
- 2026
- Brand names listed
- A/326391 Cable, A/646225 Cable, A/ABC300-11MED, A/AIRPHOTICKIT, A/CE620NK, A/DCIN1200, A/EJ110-0010 Cable, A/FQW-50-2-100 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2025 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | OLT | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| June 10, 2025 | K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 31, 2023 | K223567 | CNS-2101 Central Monitor | MSX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 21, 2022 | K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | KOI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| December 29, 2021 | K213316 | 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 | KOI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 16, 2021 | K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System | MHX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| May 2, 2021 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | KOI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| February 7, 2020 | K191975 | Elefix V Paste for EEG & EMG | GYB | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| May 28, 2019 | K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | MWI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| October 11, 2017 | K171765 | Nihon Kohden CO2 Monitor | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| August 25, 2017 | K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | GWQ | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| May 19, 2017 | K163644 | Nihon Kohden QP-160AK EEG Trend Program | OMA | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| April 4, 2017 | K163459 | Nihon Kohden Vital Sign Telemeter | MHX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| February 24, 2017 | K161860 | TG-970P CO2 Sensor Kit | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| September 2, 2016 | K153707 | Nihon Kohden Vital Sign Telemeter | MHX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| April 8, 2016 | K152305 | Nihon Kohden Afib Detection Program QP-039P | DSI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| November 5, 2015 | K151080 | Nihon Kohden CSM 1901 Bedside Monitor | MHX | Substantially Equivalent | Nihon Kohden | accessdata.fda.gov |
| April 24, 2015 | K142624 | Neuromaster G1 MEE200 | GWF | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| March 4, 2015 | K130238 | NIHON KOHDEN AE-918P NEURO UNIT | OMA | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| May 21, 2013 | K122214 | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) | CCK | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| November 9, 2012 | K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM | GWQ | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| September 19, 2012 | K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM | GWF | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| March 22, 2012 | K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | GWQ | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| March 16, 2012 | K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | OMA | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 28, 2011 | K110594 | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS | CCK | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| August 4, 2011 | K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | GYC | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| July 29, 2011 | K110376 | PE-210AK SWITCH BOX | GWQ | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| December 7, 2010 | K102376 | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 | MHX | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| July 9, 2010 | K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | OMA | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| March 2, 2009 | K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 6, 2008 | K071969 | SEN-4100 ELECTRIC STIMULATOR | GWF | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| August 29, 2008 | K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | OLT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| February 26, 2008 | K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | MHX | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| January 11, 2008 | K073491 | EEG-1100A SWITCH BOX | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| November 29, 2007 | K072843 | YG-125T AND YG-135T NASAL ADAPTER | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| August 30, 2007 | K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M | DPS | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | DRG | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| December 27, 2006 | K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| August 17, 2005 | K051178 | MEE-1000A NEUROMASTER | GWF | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| April 29, 2005 | K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| February 3, 2005 | K043517 | TRANSMITTER, ZS-940PA SERIES | DRT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 15, 2004 | K040875 | CAP-ONE, MODEL TG-920P | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| September 16, 2003 | K032749 | BEDSIDE MONITOR, MODEL OPV-1500 | MWI | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 29, 2002 | K022121 | PSG INPUT BOX, MODEL JE-912AK | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 25, 2002 | K020046 | MULTIGAS UNIT, MODEL AG-920RA | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| September 12, 2001 | K011918 | NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES | MHX | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 28, 2001 | K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | IKN | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| May 8, 2001 | K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 14, 1999 | K992742 | NEUROFAX, MODEL EEG-1100A | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 9, 1999 | K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| March 13, 1987 | K870795 | EMG ELECTRODES AND EXTENSION CORDS | IKT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| November 13, 1986 | K862799 | SKIN PURE | GYB | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 1, 1986 | K860210 | ELEFIX ELECTRODE CREAM | GYB | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
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Updated October 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.