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Data / Medical devices / Japan / Nihon Kohden Corporation - Eastern Japan Logistics Center

Nihon Kohden Corporation - Eastern Japan Logistics Center: FDA-registered device maker in Sakado City Saitama, Japan, 53 510(k) clearances

Nihon Kohden Corporation - Eastern Japan Logistics Center is registered with the FDA (registration 3016852448) in Sakado City Saitama, Japan. It lists 39 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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Get makers like this oneWatch Nihon Kohden Corporation - Eastern Japan Logistics Center
FDA registration number
3016852448
Address
1-1 Nishi-Inter, 2-Chome, Sakado City Saitama, Japan, 350-0259
Owner or operator
NIHON KOHDEN CORP. (8030227)
Roles
Exporter to the US
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

DeviceProduct codeClassRoleSource
Amplifier And Signal Conditioner, Transducer SignalDRQ2Exporter to the USaccessdata.fda.gov
Amplitude-Integrated ElectroencephalographOMA2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Water Vapor, Gaseous-PhaseBXA1Exporter to the USaccessdata.fda.gov
Automatic Event Detection Software For Full-Montage ElectroencephalographOMB2Exporter to the USaccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Exporter to the USaccessdata.fda.gov
Connector, Airway (Extension)BZA1Exporter to the USaccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Exporter to the USaccessdata.fda.gov
Device, Galvanic Skin Response MeasurementGZO2Exporter to the USaccessdata.fda.gov
Device, Nerve Conduction Velocity MeasurementJXE2Exporter to the USaccessdata.fda.gov
ElectrocardiographDPS2Exporter to the USaccessdata.fda.gov
Electrode, CorticalGYC2Exporter to the USaccessdata.fda.gov
Electrode, CutaneousGXY2Exporter to the USaccessdata.fda.gov
Electrode, Ion Selective (Non-Specified)JJP1Exporter to the USaccessdata.fda.gov
Electrode, Needle, Diagnostic ElectromyographIKT2Exporter to the USaccessdata.fda.gov
Electromyograph, DiagnosticIKN2Exporter to the USaccessdata.fda.gov
Endoscopic Bite BlockMNK1Exporter to the USaccessdata.fda.gov
Full-Montage Standard ElectroencephalographGWQ2Exporter to the USaccessdata.fda.gov
Gas, Collecting VesselKGK1Exporter to the USaccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Exporter to the USaccessdata.fda.gov
Media, ElectroconductiveGYB2Exporter to the USaccessdata.fda.gov
Monitor, Bed PatientKMI1Exporter to the USaccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Exporter to the USaccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Exporter to the USaccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Exporter to the USaccessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT2Exporter to the USaccessdata.fda.gov
ProbeHXB1Exporter to the USaccessdata.fda.gov
Probe, EntKAK1Exporter to the USaccessdata.fda.gov
Probe, Uptake, NuclearIZD1Exporter to the USaccessdata.fda.gov
Reduced- Montage Standard ElectroencephalographOMC2Exporter to the USaccessdata.fda.gov
Standard Polysomnograph With ElectroencephalographOLV2Exporter to the USaccessdata.fda.gov
Stimulator, Auditory, Evoked ResponseGWJ2Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Exporter to the USaccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Exporter to the USaccessdata.fda.gov
Stimulator, Photic, Evoked ResponseGWE2Exporter to the USaccessdata.fda.gov
Support, ArmIOY1Exporter to the USaccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Exporter to the USaccessdata.fda.gov
Tester, Electrode/Lead, ElectroencephalographGYA1Exporter to the USaccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Exporter to the USaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 9, 2025K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)OLTSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
June 10, 2025K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCKSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
July 31, 2023K223567CNS-2101 Central MonitorMSXSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
July 21, 2022K220976Life Scope PT BSM-1700 Series Bedside MonitorKOISubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
December 29, 2021K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOISubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
July 16, 2021K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHXSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
May 2, 2021K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOISubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
February 7, 2020K191975Elefix V Paste for EEG & EMGGYBSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
May 28, 2019K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorMWISubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
March 19, 2019K183529AE-120A EEG Head SetOMCSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
October 11, 2017K171765Nihon Kohden CO2 MonitorCCKSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
August 25, 2017K171124Nihon Kohden Wireless Input Unit WEE-1200GWQSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
May 19, 2017K163644Nihon Kohden QP-160AK EEG Trend ProgramOMASubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
April 4, 2017K163459Nihon Kohden Vital Sign TelemeterMHXSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
February 24, 2017K161860TG-970P CO2 Sensor KitCCKSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
September 2, 2016K153707Nihon Kohden Vital Sign TelemeterMHXSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
April 8, 2016K152305Nihon Kohden Afib Detection Program QP-039PDSISubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
November 5, 2015K151080Nihon Kohden CSM 1901 Bedside MonitorMHXSubstantially EquivalentNihon Kohdenaccessdata.fda.gov
April 24, 2015K142624Neuromaster G1 MEE200GWFSubstantially EquivalentNihon Kohden Corporationaccessdata.fda.gov
March 4, 2015K130238NIHON KOHDEN AE-918P NEURO UNITOMASubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
May 21, 2013K122214TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)CCKSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
November 9, 2012K120888PSG-1100 SLEEP DIAGNOSTIC SYSTEMGWQSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
September 19, 2012K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEMGWFSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
March 22, 2012K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXGWQSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
March 16, 2012K120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT POMASubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
October 28, 2011K110594GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORSCCKSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
August 4, 2011K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)GYCSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
July 29, 2011K110376PE-210AK SWITCH BOXGWQSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
December 7, 2010K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201MHXSubstantially EquivalentNihon Kohden Corp.accessdata.fda.gov
July 9, 2010K092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMOMASubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
March 2, 2009K083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PCCKSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
October 6, 2008K071969SEN-4100 ELECTRIC STIMULATORGWFSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
August 29, 2008K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200AOLTSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
February 26, 2008K080342NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIESMHXSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
January 11, 2008K073491EEG-1100A SWITCH BOXOLVSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
November 29, 2007K072843YG-125T AND YG-135T NASAL ADAPTERCCKSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
August 30, 2007K072217ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX MDPSSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
June 29, 2007K071058MULTIPLE PATIENT RECEIVER, MODEL ORG-9700ADRGSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
December 27, 2006K062115CARBON DIOXIDE MONITOR, MODEL OLG-2800ACCKSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
August 17, 2005K051178MEE-1000A NEUROMASTERGWFSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
April 29, 2005K050833ELECTRODE JUNCTION BOX, MODEL JE-921AOLVSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
February 3, 2005K043517TRANSMITTER, ZS-940PA SERIESDRTSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
October 15, 2004K040875CAP-ONE, MODEL TG-920PCCKSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
September 16, 2003K032749BEDSIDE MONITOR, MODEL OPV-1500MWISubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
July 29, 2002K022121PSG INPUT BOX, MODEL JE-912AKOLVSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
September 12, 2001K011918NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIESMHXSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
June 28, 2001K010590NEUROPACK MICRO, MODEL MED-9100A SERIESIKNSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
May 8, 2001K011204NEUROFAX, MODELS EEG-1100A, EEG-9100AOLVSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
October 14, 1999K992742NEUROFAX, MODEL EEG-1100AOLVSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
June 9, 1999K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESCCKSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
March 13, 1987K870795EMG ELECTRODES AND EXTENSION CORDSIKTSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
November 13, 1986K862799SKIN PUREGYBSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov
July 1, 1986K860210ELEFIX ELECTRODE CREAMGYBSubstantially EquivalentNihon Kohden America, Inc.accessdata.fda.gov

Compare with other makers

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.