BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NIHON KOHDEN AMERICA, INC.

    Reg #: 2080783 · FEI: 2080783 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    556
    Establishment Types
    3
    Classifications
    49

    Registration Details

    Registration Name
    NIHON KOHDEN AMERICA, INC.
    Registration Number
    2080783
    FEI Number
    2080783
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    15353 Barranca Pkwy
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    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

    Products

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

    Proprietary Names

    TL-201T JE-912AK TL-274T TL-062S TL-220T TL-052S JL-951T3 TL-271T CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P Nihon Kohden TG-970P Sensor Kit w/ Airway Adapter YG-213T YG-213T EEG-1100A Switchbox 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 AG-920RA AG-920RA Mulitgas Unit Probe TL-630T3 BR-903PA JC-103TA YN-121T YN-990P YN-101T BR-913PA IF-920P YJ-671P IF-950P QF-921P JT-900P QF-908P IF-925P YG-211T LIFE SCOPE® G9 YS-106P9 BSM-1753 IF-19004 IF-935P AY-673P A/EJ110-0010 Cable YN-901P QF-902P TL-271T3 IF-961P IF-948P QF-907P IF-932P YL-920P DH-170P YS-108P1 TG-101T BSM-1773 YS-106P6 JL-500P1 JP-910P IF-928P IF-922P YJ-920P YS-105P6 YP-814P IF-944P YN-921P QF-909P JA-690PA IF-958P DM-190P IF-937P IF-957P AY-653P YP-812P AA-674P IF-912P YP-815P QF-911P YJ-910P BJ-900PA IF-943P IF-954P YS-106P5 YS-105P0 DM-191P JL-900P TL-273T3 IF-956P IF-930P YS-105P5 IF-916P YS-108P0 TL-631T3 YN-924P YS-107P1 JL-631P AY-651P JL-630P JA-920P SB-170P JA-694PA QF-801P DZ-170P YS-106P8 YP-816P YS-094P2 YN-900P YP-813P YS-107P9 TL-051S YS-105P8 TL-631T1 CU-192R A/326391 Cable WS-960P TL-273T YP-811P QF-903P YG-111T YS-105P7 IF-914P YS-107P2 TG-900P YG-101T IF-963P AY-631P TG-920P Nihon Kohden CSM-1901 Bedside Monitor AY-671P SC-170R IF-946P JP-900P YS-104P5 JP-920P IF-942P AY-633P IF-952P A/646225 Cable JL-639P RY-910PA YG-122T IF-919P YN-920P JL-632P TL-272T3 TG-970P YP-817P A/CE620NK G9-KVM/ZA YS-106P4 TL-061S JG-900P YS-19003 BR-906PA IF-923P JL-650P YS-107P4 TL-274T3 TL-272T SB-920P BSM-1733 YS-107P3 YS-108P2 QF-901P IF-951P YS-106P3 YS-106P7 JC-906PA IF-917P IF-913P YP-810P JT-950P TL-535U YN-925P DH-172P YS-100P7 YG-272T DH-171P JL-030U2 KC-170P HIT-100 JL-030U1 YG-242T YG-214T YG-232T YG-227T YG-282T DH-380P CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 BLUPRO Attachment Tape YS-111P7 (P263A) BLUPRO Attachment Tape, YS-111P7 JE-921A TG-921T3 TL-260T BR-933PA GZ-120P BR-943PA GZ-130P Nihon Kohden QP-160AK EEG Trend Program CD-237P NE-090S1 ZElectrode NE-091S7 Disposable Electrode AE-120A EEG Heatset 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 JE-225AK NE-134A 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 QI-120A NE-114A BC-112B JE-210A JE-120A-22 NK-REVSUITE-MU JE-915A KC-001A QP-160AK JE-209A A/NIH8000 A/SONYCART-3 JE-214A YL-104A A/QP-160A-VS-10 KH-122A A/AIRPHOTICKIT KH-121A JE-922A KE-122A EEG-1200A NK-LS-901AJ NK-XPPSGRD-SFF A/DCIN1200 A/QP-160A-VS-25 JE-120A-23 JL-550T1 EEG-1200A-T NK-REVSUITE-5 A/ABC300-11MED YL-103A A/NWB-HL7NIS NC-143E EEG-1200AA NE-113A JE-207A A/GCXCART A/NWB-HL7CS JE-226AK NE-311A A/POUCHTRIFOLD LS-703A JE-227AK EEG-1200A-RAID SKIN PURE EMG ELECTRODES AND EXTENSION CORDS Nihon Kohden AE-918P Neuro Unit Nihon Kohden MS-120BK Electric Stimulator QP-039P Afib Detection Program ELECTRODE/LEAD YP-845T YP-715T YP-711T YS-112P4 YP-712T YP-714T YN-980S YP-841T YP-844T YP-842T YP-710T YP-840T YP-713T GZ-140P YP-843T YN-981S 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 Nihon Kohden TG-970 CO2 Sensor Kit Electrode H072 PSG-1100 Sleep Diagnostic System 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 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 QP-947BK LS-102J KH-001A JB-910B QP-948BK NE-430B RY-960B JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B P-Blade ITL-LL Airway Scope AWS-S200 P-Blade ITL-NL P-Blade ITL-PL P-Blade ITL-SL P-Blade ITL-TL 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 Data Acquisition Unit Life Scope® BSM 6000 Series Bedside Monitoring Systems Life Scope® CSM-1901 Bedside Monitoring Systems AY Input Unit Series Life Scope® PT BSM-1700 Series MEB-2300A Neuropack Evoked Potential & EMG Measuring System PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A MULTIPLE PATIENT RECEIVER ORG-9700A 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 JS-210B JS-201B JB-210B BM-121B YG-135T MEE-2000A-DT QP-101BK DC-200B Neural Function Measuring System MEE-2000 YB-201B Neuromaster G1 MEE-2000 JS-202B JB-316B JB-232B JS-204B YG-125T VD-403B MEE-2000A-LT JS-203B P225F ORG-9100A Medical Device Gateway Communication Cable MDI-1000 IF-949P Probe CARBON DIOXIDE MONITOR, MODEL OLG-2800A BM-412B JW-120B BSM-2301A NK-ASAAPPLIANCE BSM-2351A NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR BSM-2354A 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 ANALYZER 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 Nihon Kohden JE-120A Multi Electrode Junction Box ELEFIX ELECTRODE CREAM MEE-1000A NEUROMASTER 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 GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors 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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device