BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Nihon Kohden Corporation - Eastern Japan Logistics Center

    Reg #: 3016852448 · FEI: 3016852448 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    542
    Establishment Types
    1
    Classifications
    39

    Registration Details

    Registration Name
    Nihon Kohden Corporation - Eastern Japan Logistics Center
    Registration Number
    3016852448
    FEI Number
    3016852448
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-1 Nishi-Inter, 2-Chome
    City
    Sakado City Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K022121

    Owner / Operator

    Firm Name
    NIHON KOHDEN CORP.
    Operator Number
    8030227
    Address
    1-31-4 NISHIOCHIAI, SHINJUKU-KU
    City
    TOKYO
    State
    JP-13
    Postal Code
    161-8560
    Country
    JP

    US Agent

    Business Name
    Nihon Kohden America, LLC
    Contact Name
    Charlemagne Chua
    Address
    15353 Barranca Parkway
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ
    Amplitude-Integrated Electroencephalograph OMA
    Burst Suppression Detection Software For Electroencephalograph ORT
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Device, Galvanic Skin Response Measurement GZO
    Device, Nerve Conduction Velocity Measurement JXE
    Stimulator, Auditory, Evoked Response GWJ
    Stimulator, Electrical, Evoked Response GWF
    Electromyograph, Diagnostic IKN
    Stimulator, Photic, Evoked Response GWE
    Electrode, Cortical GYC
    Electrocardiograph DPS
    Probe, Ent KAK
    Headlamp, Operating, Battery-Operated HPP
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Media, Electroconductive GYB
    Support, Arm IOY
    Analyzer, Gas, Water Vapor, Gaseous-Phase BXA
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Gas, Collecting Vessel KGK
    Monitor, Bed Patient KMI
    Electrode, Needle, Diagnostic Electromyograph IKT
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Network And Communication, Physiological Monitors MSX
    Detector And Alarm, Arrhythmia DSI
    Probe, Uptake, Nuclear IZD
    Tester, Electrode/Lead, Electroencephalograph GYA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY
    Endoscopic Bite Block MNK
    Probe HXB
    Electrode, Ion Selective (Non-Specified) JJP
    Connector, Airway (Extension) BZA

    Proprietary Names

    TL-201T JE-912AK TL-274T TL-062S TL-220T TL-052S JL-951T3 TL-271T QP-160AK Nihon Kohden QP-160AK EEG Trend Program NMT Smart Pod Smart Cable NMT Pod, with EMG Support TOF Smart Pod TOF Pod TOF electrodes Life Scope BSM 3000 Series Bedside Monitors EMG electrodes JW-201P Main cable NMT Pod NMT electrodes AF-201P NMT module Disposable electrodes NM-345Y Disposable electrodes NMT Smart Cable TOF Pod DH-101P Holder Life Scope BSM 6000 Series Bedside Monitors Nihon Kohden TG-970P Sensor Kit w/ Airway Adapter YG-213T YG-213T QP-946BK BM-701B SC-900B DR-531B-14 KH-960A YZ-0172 RY-441B YE-103J DI-960B A/NIH9000 KD-019A BM-001B MEB-9400A-DT NE-134A QP-947BK LS-102J KH-001A JB-910B QP-948BK NE-430B RY-960B A/NWB-HL7CS JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B TG-900P YG-101T TG-101T JG-900P PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A SB-901D YZ-041H2 KD-105D BA-903D ECG-1350A ECG-1250A SERIES CARDIOFAX ECG-1250A NKB-301V DI-015D ECG-1350A SERIES CARDIOFAX KH-100D DI-014D CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T P225F Nihon Kohden TG-970 CO2 Sensor Kit TG-970P LS-703A TG-980P TG-980P1 BR-903PA JC-103TA YN-121T YN-990P YN-101T BR-913PA TG-980P CO2 Sensor Kit with Smart Connector TG-980P1 CO2 Sensor Kit with Smart Connector TG-980P CO2 Sensor Kit TG-980P1 CO2 Sensor Kit with Smart Cable TG-980P1 CO2 Sensor Kit TG-980P CO2 Sensor Kit with Smart Cable MEB-2300A Neuropack Evoked Potential & EMG Measuring System SKIN PURE GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors Nihon Kohden MS-120BK Electric Stimulator TG-921T3 JE-208A TL-273T NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS QP-110AK JE-215AK A/POUCH-JE922 LS-703AA JE-922A QI-120A JE-217AK LS-901AJ YZ-0226 A/POUCHTRIFOLD JE-209A BC-112B JE-425A JE-207A NE-311A JE-216AK NC-143E QP-150AK JE-921A JL-550T1 EEG-9100A KC-001A KE-910A JE-212A EEG-9200A ANALYZER NK-NEUROFAX-R JE-213A A/TRACKTRANS JE-120A-24 NK-CENTRAL-150 QP-160R-10 QI-123A A/RELAYBOX A/PHOTIC-3 A/SONYCART JE-225AK NK-CENTRAL-SW DI-120A EEG-1250A QI-124A AAA-17041 NK-REVSUITE-10 QI-122A QD-120A NIHON KOHDEN EEG-1200A SERIES NEUROFAX EEG-1260A NE-114A JE-210A JE-120A-22 NK-REVSUITE-MU JE-915A A/NIH8000 A/SONYCART-3 JE-214A YL-104A A/QP-160A-VS-10 KH-122A A/AIRPHOTICKIT KH-121A KE-122A EEG-1200A NK-LS-901AJ NK-XPPSGRD-SFF A/DCIN1200 A/QP-160A-VS-25 JE-120A-23 EEG-1200A-T NK-REVSUITE-5 A/ABC300-11MED YL-103A A/NWB-HL7NIS EEG-1200AA NE-113A A/GCXCART JE-226AK JE-227AK EEG-1200A-RAID EEG-1100A Switchbox TL-051S TL-273T3 TL-271T3 TL-061S TL-631T1 TL-631T3 TL-260T BR-933PA GZ-120P TL-272T TL-272T3 TL-535U TL-274T3 BR-943PA GZ-130P ELEFIX ELECTRODE CREAM PSG-1100 Sleep Diagnostic System CD-237P CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 IF-961P YP-715T QF-909P IF-963P QS-028PA YJ-910P IF-956P IF-951P JP-910P YS-096P2 IF-935P IF-942P JL-900P JL-639P QF-903P YS-096P3 JL-632P IF-950P DZ-170P JP-900P JL-631P IF-920P YP-710T IF-930P IF-913P IF-912P IF-927P IF-946P QI-632P YG-111T QI-672P YP-711T QM-600P IF-932P QI-600P QI-430PA DH-220P IF-957P JL-500P1 JP-920P IF-19004 JO-900P JT-900P YN-901P IF-916P QP-038P TR-900P YJ-920P YN-900P JT-950P A/FQW-50-2-100 YP-713T QI-373P YG-001P IF-939P IF-914P QI-610PA YG-214T IF-922P QF-901P QI-634P AA-674P IF-917P JL-630P IF-943P IF-955P BR-906PA YJ-671P YG-122T QS-065PA SC-170R YP-712T QS-042P QI-631P IF-954P YS-096P5 QF-907P QF-921P MU-651RA QI-671P QF-904P JC-906PA QF-911P YN-921P YS-63015 DH-170P YS-096P6 SB-671P JA-694PA BJ-900PA IF-919P QF-801P YN-920P IF-923P QI-320PA YP-714T MU-631RA WS-671P IF-948P QF-908P QF-902P YJ-672P IF-928P SB-170P RY-910PA NK-ASPECT-BISX MU-671RA IF-937P JL-650P IF-944P IF-925P IF-958P Life Scope® PT BSM-1700 Series Life Scope® G7H Nihon Kohden Life Scope® G7 Bedside Monitoring System Life Scope® G5L, Life Scope® G5-HD DM-150P Stand (for CU-171R, CU-172R) Life Scope® G7 H Life Scope® G5 Plus DH-157P Adapter KG-150P Wall mount kit (for CU-171R, CU-172R) QI-152P Side option board for CU-152R Life Scope® G5 Lite Life Scope® G7 with (DAU) Data Acquisition Module DH-190P Unit holder CU-171R Core unit Life Scope® G5 Max G5 All-in-one Patient Monitor Life Scope® G7 High Acuity Monitor Nihon Kohden Life Scope® G5 Bedside Monitoring System Life Scope® G5L Life Scope® G5-HD YS-116P0 SSD Expansion Board QI-152P Side option board Life Scope® G5 X QI-151P Rear option board for CU-151R/CU-152R SB-950P Battery Pack DZ-150P Handle (for CU-151R, CU-152R) Life Scope® G5 Life Scope® G5 H DH-159P Unit holder CU-152R Core unit Life Scope® G5 Min WS-171P Recorder Unit CU-171R/CU-172R KC-150P Cart (for CU-171R, CU-172R) DH-150P Unit holder JA-170P Data Acquisition Unit QM-151P SD Card CU-172R Core unit DH-151P Adapter SB-970P Battery Pack DH-154P IF holder QS-127PA Software Kit DH-158P GF holder CU-151R Core unit AA-174P Multi Amp Unit QS-116PA Software Kit QI-171P Rear option board CU-171R/CU-172R WS-151P Recorder Unit DH-153P Recorder holder DH-152P Channel adapter DH-156P Unit holder DH-155P Holder ORG-9100A Nihon Kohden JE-120A Multi Electrode Junction Box TG-920P YG-135T YG-125T EMG ELECTRODES AND EXTENSION CORDS CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P BM-412B JW-120B QP-039P Afib Detection Program Probe ELECTRODE/LEAD LIFE SCOPE® G9 YS-106P9 BSM-1753 AY-673P A/EJ110-0010 Cable YL-920P YS-108P1 BSM-1773 YS-106P6 YS-105P6 YP-814P JA-690PA DM-190P AY-653P YP-812P YP-815P YS-106P5 YS-105P0 DM-191P YS-105P5 YS-108P0 YN-924P YS-107P1 AY-651P JA-920P YS-106P8 YP-816P YS-094P2 YP-813P YS-107P9 YS-105P8 CU-192R A/326391 Cable WS-960P YP-811P YS-105P7 YS-107P2 AY-631P Nihon Kohden CSM-1901 Bedside Monitor AY-671P YS-104P5 AY-633P IF-952P A/646225 Cable YP-817P A/CE620NK G9-KVM/ZA YS-106P4 YS-19003 YS-107P4 SB-920P BSM-1733 YS-107P3 YS-108P2 YS-106P3 YS-106P7 YP-810P YN-925P YP-845T YS-112P4 YN-980S YP-841T YP-844T YP-842T YP-840T GZ-140P YP-843T JL-030U2 YN-981S JL-030U1 A/NTX-DISP ZM-530PA ZM-521PA ZM-541PA ZS-940PA YP-504P ZM-520PA YP-944P A/NTX2-POUCH BR-916PA ZM-531PA ZM-540PA YP-503P YP-943P Nihon Kohden AE-918P Neuro Unit NE-090S1 ZElectrode NE-091S7 Disposable Electrode AE-120A EEG Heatset Data Acquisition Unit Life Scope® BSM 6000 Series Bedside Monitoring Systems Life Scope® CSM-1901 Bedside Monitoring Systems AY Input Unit Series BSM-2301A NK-ASAAPPLIANCE BSM-2351A NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR BSM-2354A DH-172P YS-100P7 YG-272T DH-171P KC-170P HIT-100 YG-242T YG-232T YG-227T YG-282T DH-380P MULTIPLE PATIENT RECEIVER ORG-9700A Probe TL-630T3 JW-124A DH-120A JL-570T ZB-120A KC-120A YC-120A JW-126A JW-122A JW-125A MU-120A SB-121A SB-120A JE-125AK JW-121A JW-120A JW-123A Electrode H072 YG-220T cap-ONE Nasal Adapter, Pediatric, w/ Oxygen tube YG-221T YG-231T YG-230T cap-ONE Nasal Adapter, Pediatric cap-ONE Nasal Adapter, Adult, w/ Oxygen tube cap-ONE Nasal Adapter, Adult YG-235T YG-213T-A1 YG-225T QP-101BK MEE-1000A NEUROMASTER JS-210B JS-201B JB-210B BM-121B MEE-2000A-DT DC-200B Neural Function Measuring System MEE-2000 YB-201B Neuromaster G1 MEE-2000 JS-202B JB-316B JB-232B JS-204B VD-403B MEE-2000A-LT JS-203B QP-160AK EEG TREND PROGRAM

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device