BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NIHON KOHDEN CORP.

    Reg #: 9611252 · FEI: 3002807720 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    549
    Establishment Types
    1
    Classifications
    48

    Registration Details

    Registration Name
    NIHON KOHDEN CORP.
    Registration Number
    9611252
    FEI Number
    3002807720
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    31-4 NISHIOCHIAI, 1-CHOME,
    City
    SHINJUKU-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K071058

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

    Proprietary Names

    MULTIPLE PATIENT RECEIVER ORG-9700A QP-160AK BM-412B JW-120B KH-001A CD-237P YP-845T BR-943PA YP-715T TL-272T3 YP-810P BR-906PA YP-817P TL-062S TL-061S YP-711T BR-903PA YS-112P4 TL-201T YP-712T TL-535U YP-811P YP-714T TL-051S TL-220T YN-980S YP-841T YP-844T TL-271T3 TL-631T1 TL-271T YP-842T YP-710T YP-840T YP-812P TL-273T TL-052S TL-274T YP-713T YP-813P TL-272T YP-815P YP-816P GZ-140P YP-843T TL-273T3 JL-030U2 BR-933PA YN-981S TL-631T3 TL-260T YP-814P JL-030U1 TL-274T3 CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P Life Scope® PT BSM-1700 Series BSM-2301A JP-900P YN-900P NK-ASAAPPLIANCE 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 YN-921P AG-920RA AG-920RA Mulitgas Unit Probe TL-630T3 Nihon Kohden AE-918P Neuro Unit QP-039P Afib Detection Program SKIN PURE P225F CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T TG-980P TG-970P TG-980P1 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 QP-160AK EEG TREND PROGRAM 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 JE-921A TG-921T3 Probe JE-208A LS-703A NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS QP-110AK JE-215AK A/POUCH-JE922 LS-703AA JE-922A QI-120A NE-134A 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-912AK JL-550T1 EEG-9100A KC-001A KE-910A JE-212A EEG-9200A SB-170P DH-172P YS-100P7 YG-272T DH-171P YG-213T KC-170P JL-500P1 HIT-100 YG-242T YG-214T YG-232T YG-227T TG-920P YG-282T DH-380P JL-951T3 YG-135T YG-125T 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 EMG ELECTRODES AND EXTENSION CORDS Nihon Kohden TG-970P Sensor Kit w/ Airway Adapter YG-213T JS-210B JS-201B JB-210B BM-121B NE-114A 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 VD-403B MEE-2000A-LT DR-531B-14 JS-203B EEG-1100A Switchbox 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 JC-103TA YN-121T YN-101T ANALYZER Decoration parts Nihon Kohden MS-120BK Electric Stimulator PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A IF-920P YJ-671P IF-950P QF-921P JT-900P QF-908P IF-925P LIFE SCOPE® G9 YS-106P9 BSM-1753 IF-19004 IF-935P AY-673P A/EJ110-0010 Cable QF-902P IF-961P IF-948P QF-907P IF-932P YL-920P DH-170P YS-108P1 BSM-1773 YS-106P6 IF-928P IF-922P YJ-920P YS-105P6 IF-944P QF-909P JA-690PA IF-958P DM-190P IF-937P IF-957P AY-653P AA-674P IF-912P QF-911P YJ-910P BJ-900PA IF-943P IF-954P YS-106P5 YS-105P0 DM-191P IF-956P IF-930P YS-105P5 IF-916P YS-108P0 YN-924P YS-107P1 JL-631P AY-651P JL-630P JA-920P JA-694PA QF-801P DZ-170P YS-106P8 YS-094P2 YS-107P9 YS-105P8 CU-192R A/326391 Cable WS-960P QF-903P YS-105P7 IF-914P YS-107P2 IF-963P AY-631P Nihon Kohden CSM-1901 Bedside Monitor AY-671P SC-170R IF-946P YS-104P5 IF-942P AY-633P IF-952P A/646225 Cable JL-639P RY-910PA IF-919P JL-632P A/CE620NK G9-KVM/ZA YS-106P4 YS-19003 IF-923P JL-650P YS-107P4 SB-920P BSM-1733 YS-107P3 YS-108P2 QF-901P IF-951P YS-106P3 YS-106P7 IF-917P IF-913P JT-950P YN-925P Nihon Kohden TG-970 CO2 Sensor Kit PSG-1100 Sleep Diagnostic System Nihon Kohden JE-120A Multi Electrode Junction Box 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 JE-225AK JW-123A ELECTRODE/LEAD Medical Device Gateway Communication Cable MDI-1000 IF-949P Nihon Kohden QP-160AK EEG Trend Program ELEFIX ELECTRODE CREAM QS-028PA YS-096P2 YS-096P3 IF-927P QI-632P QI-672P QM-600P QI-600P QI-430PA DH-220P JO-900P QP-038P TR-900P A/FQW-50-2-100 QI-373P YG-001P IF-939P QI-610PA QI-634P IF-955P QS-065PA QS-042P QI-631P YS-096P5 MU-651RA QI-671P QF-904P YS-63015 YS-096P6 SB-671P QI-320PA MU-631RA WS-671P YJ-672P NK-ASPECT-BISX MU-671RA MEE-1000A NEUROMASTER BLUPRO Attachment Tape YS-111P7 (P263A) BLUPRO Attachment Tape, YS-111P7 MEB-2300A Neuropack Evoked Potential & EMG Measuring System 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 GZ-120P GZ-130P 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 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 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 A/GCXCART JE-226AK JE-227AK EEG-1200A-RAID QP-946BK SC-900B KH-960A YZ-0172 RY-441B DI-960B A/NIH9000 KD-019A BM-001B MEB-9400A-DT QP-947BK JB-910B QP-948BK NE-430B RY-960B JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B 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 A/NTX-DISP ZM-530PA ZM-521PA ZM-541PA ZS-940PA YP-504P ZM-520PA YP-944P A/NTX2-POUCH ZM-531PA ZM-540PA YP-503P YP-943P GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility