BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center

    Reg #: 3013501110 · FEI: 3013501110 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    533
    Establishment Types
    2
    Classifications
    47

    Registration Details

    Registration Name
    Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center
    Registration Number
    3013501110
    FEI Number
    3013501110
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-1-6 Kusunokidai, Tokorozawa-Shi, Saitama
    City
    Tokorozawa Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K120397

    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 Pkwy, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

    Device Name Product Code
    Stimulator, Electrical, Evoked Response GWF
    Stimulator, Photic, Evoked Response GWE
    Stimulator, Auditory, Evoked Response GWJ
    Full-Montage Standard Electroencephalograph GWQ
    Device, Galvanic Skin Response Measurement GZO
    Electromyograph, Diagnostic IKN
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Standard Polysomnograph With Electroencephalograph OLV
    Electrode, Needle, Diagnostic Electromyograph IKT
    Probe, Uptake, Nuclear IZD
    Monitor, Bed Patient KMI
    Probe HXB
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Media, Electroconductive GYB
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Electrocardiograph DPS
    Tape And Bandage, Adhesive KGX
    Amplitude-Integrated Electroencephalograph OMA
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Ion Selective (Non-Specified) JJP
    Connector, Airway (Extension) BZA
    Device, Nerve Conduction Velocity Measurement JXE
    Headlamp, Operating, Battery-Operated HPP
    Burst Suppression Detection Software For Electroencephalograph ORT
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Water Vapor, Gaseous-Phase BXA
    Probe, Ent KAK
    Medical Device Data System OUG
    Stimulator, Nerve, Peripheral, Electric KOI
    Gas, Collecting Vessel KGK
    Tester, Electrode/Lead, Electroencephalograph GYA
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Support, Arm IOY
    Endoscopic Bite Block MNK
    Electrode, Cortical GYC
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Network And Communication, Physiological Monitors MSX
    Laryngoscope, Rigid CCW

    Proprietary Names

    MEB-2300A Neuropack Evoked Potential & EMG Measuring System TL-051S TL-273T3 TL-062S TL-273T TL-271T3 TL-061S TL-631T1 TL-220T TL-631T3 TL-260T BR-933PA GZ-120P TL-272T TL-272T3 TL-535U TL-274T TL-274T3 TL-052S BR-943PA GZ-130P TL-271T TL-201T TG-980P CO2 Sensor Kit with Smart Connector TG-980P1 CO2 Sensor Kit with Smart Connector TG-980P CO2 Sensor Kit TG-980P TG-980P1 CO2 Sensor Kit with Smart Cable TG-980P1 CO2 Sensor Kit TG-980P1 TG-980P CO2 Sensor Kit with Smart Cable JW-124A DH-120A JL-570T ZB-120A KC-120A JE-922A YC-120A JW-126A JW-122A JW-125A MU-120A SB-121A SB-120A JE-125AK JW-121A JW-120A JE-225AK JW-123A BSM-2301A JP-900P YN-900P NK-ASAAPPLIANCE BR-906PA TG-900P YN-901P YN-920P YG-122T YN-990P JL-900P JP-910P BSM-2351A BR-916PA JG-900P YG-111T TG-101T JC-906PA NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR BSM-2354A YG-101T JP-920P BR-913PA BR-903PA YN-921P EMG ELECTRODES AND EXTENSION CORDS Probe ORG-9100A Probe TL-630T3 JS-210B JS-201B JB-210B BM-121B NE-114A JL-550T1 YG-135T TG-921T3 QI-120A MEE-2000A-DT QP-101BK DC-200B Neural Function Measuring System MEE-2000 YB-201B Neuromaster G1 MEE-2000 NE-113A JS-202B BM-701B YE-103J JB-316B JB-232B JS-204B LS-102J A/NWB-HL7CS YG-125T NE-134A VD-403B MEE-2000A-LT DR-531B-14 JS-203B NK-NEUROFAX-R JE-213A A/TRACKTRANS JE-120A-24 NK-CENTRAL-150 QP-160R-10 QI-123A A/RELAYBOX JE-212A A/PHOTIC-3 A/SONYCART JE-208A NK-CENTRAL-SW DI-120A EEG-1250A QP-110AK QI-124A AAA-17041 NK-REVSUITE-10 QI-122A A/POUCH-JE922 QD-120A NIHON KOHDEN EEG-1200A SERIES NEUROFAX EEG-1260A BC-112B JE-210A JE-120A-22 NK-REVSUITE-MU JE-915A KC-001A JE-921A QP-160AK JE-209A 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 NC-143E EEG-1200AA JE-207A A/GCXCART JE-226AK NE-311A A/POUCHTRIFOLD LS-703A JE-227AK EEG-1200A-RAID BM-412B JW-120B SKIN PURE IF-961P YP-715T QF-909P IF-963P QS-028PA YJ-910P IF-956P IF-951P YS-096P2 IF-935P IF-942P JL-639P QF-903P YS-096P3 JL-632P IF-950P DZ-170P JL-631P IF-920P YP-710T IF-930P IF-913P IF-912P IF-927P IF-946P QI-632P QI-672P YP-711T QM-600P IF-932P QI-600P QI-430PA DH-220P IF-957P JL-500P1 IF-19004 JO-900P JT-900P YG-211T IF-916P QP-038P TR-900P YJ-920P 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 YJ-671P QS-065PA SC-170R YP-712T QS-042P QI-631P IF-954P YS-096P5 QF-907P YG-213T QF-921P MU-651RA QI-671P QF-904P QF-911P YS-63015 DH-170P YS-096P6 SB-671P JA-694PA BJ-900PA IF-919P QF-801P IF-923P CD-237P 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 AG-920RA AG-920RA Mulitgas Unit TG-970P 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 JE-912AK JL-951T3 CARBON DIOXIDE MONITOR, MODEL OLG-2800A GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors BLUPRO Attachment Tape YS-111P7 (P263A) BLUPRO Attachment Tape, YS-111P7 MEE-1000A NEUROMASTER Nihon Kohden AE-918P Neuro Unit MULTIPLE PATIENT RECEIVER ORG-9700A 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-946BK SC-900B KH-960A YZ-0172 RY-441B DI-960B A/NIH9000 KD-019A BM-001B MEB-9400A-DT QP-947BK KH-001A JB-910B QP-948BK NE-430B RY-960B JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B PSG-1100 Sleep Diagnostic System Nihon Kohden QP-160AK EEG Trend Program TG-920P NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS JE-215AK LS-703AA JE-217AK LS-901AJ YZ-0226 JE-425A JE-216AK QP-150AK EEG-9100A KE-910A EEG-9200A QP-039P Afib Detection Program ANALYZER P225F Medical Device Gateway Communication Cable MDI-1000 IF-949P 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 Data Acquisition Unit Life Scope® BSM 6000 Series Bedside Monitoring Systems Life Scope® CSM-1901 Bedside Monitoring Systems AY Input Unit Series CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 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 ELECTRODE/LEAD Nihon Kohden TG-970 CO2 Sensor Kit DH-172P YS-100P7 YG-272T DH-171P JL-030U2 KC-170P HIT-100 JL-030U1 YG-242T YG-232T YG-227T YG-282T DH-380P ELEFIX ELECTRODE CREAM YP-845T YS-112P4 YN-980S YP-841T YP-844T YP-842T YP-840T GZ-140P YP-843T YN-981S PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P 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 P-Blade ITL-LL Airway Scope AWS-S200 P-Blade ITL-NL P-Blade ITL-PL P-Blade ITL-SL P-Blade ITL-TL

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198