FDA.reportPublic FDA data

Nihon Kohden Digital Health Solutions, LLC.

Matched from indexed company URL: NIHON KOHDEN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20322333003142870Nihon Kohden Digital Health Solutions, LLC.1N2026-01-0114 Bunsen IRVINE CA US 92618
20807832080783NIHON KOHDEN AMERICA, INC.1Y2026-01-0115353 Barranca Pkwy Irvine CA US 92618
30079627243007962724Nihon Kohden Tomioka Corporation1N2026-01-01486 Nanokaichi Gunma Tokyo JP 370-2343
30146312523014631252NIHON KOHDEN ORANGEMED, LLC1Y2026-01-011800 E. Wilshire Avenue Santa Ana CA US 92705
30168524483016852448Nihon Kohden Corporation - Eastern Japan Logistics Center1N2026-01-011-1 Nishi-Inter, 2-Chome Sakado City Saitama JP 350-0259
30301548143030154814Nihon Kohden America Fulfillment Center1Y2026-01-0120091 Ellipse, Suite 100 Foothill Ranch CA US 92610

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00841983100673NA - CO2 adapter for TG-900P+1(800)325-0283info@nkusa.com
00841983101434NA - CO2 sensor for TG-900P+1(800)325-0283info@nkusa.com
00841983102295NA - Carbon Dioxide Monitor+1(800)325-0283info@nkusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
104771990331356K992742NEUROFAX, MODEL EEG-1100AOLV1999-10-14
3263861990331356K992742NEUROFAX, MODEL EEG-1100AOLV1999-10-14
104771651367674K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESCCK1999-06-09
3263861651367674K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESCCK1999-06-09
104771762966400K896359AG-820PA FI02 MODULECCL1990-03-09
104771559027786K870795EMG ELECTRODES AND EXTENSION CORDSIKT1987-03-13
3263861559027786K870795EMG ELECTRODES AND EXTENSION CORDSIKT1987-03-13
104771889468296K862799SKIN PUREGYB1986-11-13
3263861889468296K862799SKIN PUREGYB1986-11-13
104771924567895K860210ELEFIX ELECTRODE CREAMGYB1986-07-01
3263861924567895K860210ELEFIX ELECTRODE CREAMGYB1986-07-01
104771135168159K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10
3240921135168159K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10
3263861135168159K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10
104761257105966K242750Central StationMSX2025-06-05
2252631372391918K231778Nihon Kohden NKV-550 Series Ventilator SystemCBK2024-03-01
104771981150320K223567CNS-2101 Central MonitorMSX2023-07-31
3263861981150320K223567CNS-2101 Central MonitorMSX2023-07-31
2252631257728897K222644Nihon Kohden NKV-440 Ventilator SystemCBK2023-05-31
104761358055951K220989Next Generation NetKonnectMHX2022-07-29
104771685922130K220976Life Scope PT BSM-1700 Series Bedside MonitorKOI2022-07-21
3263861685922130K220976Life Scope PT BSM-1700 Series Bedside MonitorKOI2022-07-21
2252631828013690K213521Nihon Kohden NKV-330 Ventilator SystemMNT2022-07-01
104771434330346K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29
2759901434330346K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29
3263861434330346K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29
104771812109675K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHX2021-07-16
3263861812109675K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHX2021-07-16
104771667617011K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02
2759901667617011K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02
3263861667617011K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02
2252631079783301K192307Nihon Kohden NKV-550 Series Ventilator SystemCBK2020-01-10
104771220682259K191975Elefix V Paste for EEG & EMGGYB2020-02-07
3263861220682259K191975Elefix V Paste for EEG & EMGGYB2020-02-07
3263861699788087K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorMWI2019-05-28
104771415096514K183529AE-120A EEG Head SetOMC2019-03-19
3263861415096514K183529AE-120A EEG Head SetOMC2019-03-19
2252631059927604K181695Nihon Kohden NKV-550 Series Ventilator SystemCBK2018-12-07
104771440083996K171765Nihon Kohden CO2 MonitorCCK2017-10-11
3263861440083996K171765Nihon Kohden CO2 MonitorCCK2017-10-11
104771475918561K171124Nihon Kohden Wireless Input Unit WEE-1200GWQ2017-08-25
3263861475918561K171124Nihon Kohden Wireless Input Unit WEE-1200GWQ2017-08-25
104771996697256K163644Nihon Kohden QP-160AK EEG Trend ProgramOMA2017-05-19
3263861996697256K163644Nihon Kohden QP-160AK EEG Trend ProgramOMA2017-05-19
104771412426141K163459Nihon Kohden Vital Sign TelemeterMHX2017-04-04
3263861412426141K163459Nihon Kohden Vital Sign TelemeterMHX2017-04-04
104771156139723K161860TG-970P CO2 Sensor KitCCK2017-02-24
3263861156139723K161860TG-970P CO2 Sensor KitCCK2017-02-24
104771643810490K153707Nihon Kohden Vital Sign TelemeterMHX2016-09-02
3263861643810490K153707Nihon Kohden Vital Sign TelemeterMHX2016-09-02
104771679101652K152305Nihon Kohden Afib Detection Program QP-039PDSI2016-04-08
3263861679101652K152305Nihon Kohden Afib Detection Program QP-039PDSI2016-04-08
104771284169666K151080Nihon Kohden CSM 1901 Bedside MonitorMHX2015-11-05
3263861284169666K151080Nihon Kohden CSM 1901 Bedside MonitorMHX2015-11-05
104771219419736K142624Neuromaster G1 MEE200GWF2015-04-24
2759901219419736K142624Neuromaster G1 MEE200GWF2015-04-24
3263861219419736K142624Neuromaster G1 MEE200GWF2015-04-24
104771354820197K130238NIHON KOHDEN AE-918P NEURO UNITOMA2015-03-04
3263861354820197K130238NIHON KOHDEN AE-918P NEURO UNITOMA2015-03-04
104771540196992K122214TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)CCK2013-05-21
3263861540196992K122214TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)CCK2013-05-21
104771891125060K120888PSG-1100 SLEEP DIAGNOSTIC SYSTEMGWQ2012-11-09
3263861891125060K120888PSG-1100 SLEEP DIAGNOSTIC SYSTEMGWQ2012-11-09
104771461647732K120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT POMA2012-03-16
3263861461647732K120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT POMA2012-03-16
104772048973857K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEMGWF2012-09-19
2759902048973857K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEMGWF2012-09-19
3263862048973857K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEMGWF2012-09-19
104771683333273K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXGWQ2012-03-22
3263861683333273K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXGWQ2012-03-22
104761255766696K112637NETKONNECT REMOTE NETWORK EXTENSIONMHX2011-12-09
104771914849420K110594GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORSCCK2011-10-28
3263861914849420K110594GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORSCCK2011-10-28
104771970840490K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)GYC2011-08-04
3263861970840490K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)GYC2011-08-04
104771624172679K110376PE-210AK SWITCH BOXGWQ2011-07-29
2759901624172679K110376PE-210AK SWITCH BOXGWQ2011-07-29
3263861624172679K110376PE-210AK SWITCH BOXGWQ2011-07-29
104761566802312K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201MHX2010-12-07
104771566802312K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201MHX2010-12-07
3263861566802312K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201MHX2010-12-07
104761388734257K102106NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATIONDRG2010-12-17
3263861296908231K092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMOMA2010-07-09
104771844802226K083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PCCK2009-03-02
3263861844802226K083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PCCK2009-03-02
104761457366360K083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYMHX2008-12-24
104771345223457K082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIESMHX2008-11-26
104771481627504K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200AOLT2008-08-29
2759901481627504K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200AOLT2008-08-29
3263861481627504K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200AOLT2008-08-29
104771680931383K080342NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIESMHX2008-02-26
3263861680931383K080342NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIESMHX2008-02-26
104761678981350K073550PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATIONMHX2008-03-28
104772008151252K073491EEG-1100A SWITCH BOXOLV2008-01-11
3263862008151252K073491EEG-1100A SWITCH BOXOLV2008-01-11
104771845329765K072843YG-125T AND YG-135T NASAL ADAPTERCCK2007-11-29
3263861845329765K072843YG-125T AND YG-135T NASAL ADAPTERCCK2007-11-29
104771662696327K072217ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX MDPS2007-08-30
3240921662696327K072217ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX MDPS2007-08-30
3263861662696327K072217ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX MDPS2007-08-30
104771378273106K071969SEN-4100 ELECTRIC STIMULATORGWF2008-10-06
2759901378273106K071969SEN-4100 ELECTRIC STIMULATORGWF2008-10-06
3263861378273106K071969SEN-4100 ELECTRIC STIMULATORGWF2008-10-06
104771860913624K071058MULTIPLE PATIENT RECEIVER, MODEL ORG-9700ADRG2007-06-29
3240921860913624K071058MULTIPLE PATIENT RECEIVER, MODEL ORG-9700ADRG2007-06-29
3263861860913624K071058MULTIPLE PATIENT RECEIVER, MODEL ORG-9700ADRG2007-06-29
104771765571795K062115CARBON DIOXIDE MONITOR, MODEL OLG-2800ACCK2006-12-27
3240921765571795K062115CARBON DIOXIDE MONITOR, MODEL OLG-2800ACCK2006-12-27
3263861765571795K062115CARBON DIOXIDE MONITOR, MODEL OLG-2800ACCK2006-12-27
104771891392121K052511CARDIOFAX CE, MODEL ECG-1500 ADPS2006-05-24
104771627481930K051178MEE-1000A NEUROMASTERGWF2005-08-17
2759901627481930K051178MEE-1000A NEUROMASTERGWF2005-08-17
3240921627481930K051178MEE-1000A NEUROMASTERGWF2005-08-17
3263861627481930K051178MEE-1000A NEUROMASTERGWF2005-08-17
104771420882030K050833ELECTRODE JUNCTION BOX, MODEL JE-921AOLV2005-04-29
3240921420882030K050833ELECTRODE JUNCTION BOX, MODEL JE-921AOLV2005-04-29
3263861420882030K050833ELECTRODE JUNCTION BOX, MODEL JE-921AOLV2005-04-29
104771260346519K043517TRANSMITTER, ZS-940PA SERIESDRT2005-02-03
3240921260346519K043517TRANSMITTER, ZS-940PA SERIESDRT2005-02-03
3263861260346519K043517TRANSMITTER, ZS-940PA SERIESDRT2005-02-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CCK262025-06-10
MHX252022-07-29
GWF132015-04-24
OLV132008-01-11
GWQ92017-08-25
KOI82022-07-21
OMA72017-05-19
GYB62020-02-07
CBK42024-03-01
DRG42010-12-17
DPS42007-08-30
MSX32025-06-05
MWI32019-05-28
OLT32008-08-29
DRT32005-02-03
IKN32001-06-28
OMC22019-03-19
DSI22016-04-08
GYC22011-08-04
IKT21987-03-13
MNT12022-07-01
CCL11990-03-09

PMN#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next