Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030229

FEI Number

3002807739

Entity Name

NIHON KOHDEN TOMIOKA PRODUCTION CENTER

City/State/Country

TOMIOKA-SHI Gunma, JP

Establishment Address

1-1 Tajino, TOMIOKA-SHI Gunma 370-2314, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIHON KOHDEN CORP. (Owner Number: 8030227)

Owner / Operator Contact Address

1-31-4 NISHIOCHIAI, SHINJUKU-KU, TOKYO, JP-13 161-8560, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011204

PMA Number

N/A

All Registered Proprietary Names

GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors 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 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-213T YG-235T YG-214T YG-213T-A1 YG-225T YG-211T 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 TL-631T3 DZ-170P JP-900P TL-201T JL-631P IF-920P YP-710T IF-930P IF-913P TL-052S IF-912P IF-927P IF-946P TL-274T QI-632P YG-111T TG-101T QI-672P YP-711T QM-600P TL-272T3 IF-932P QI-600P QI-430PA DH-220P JG-900P IF-957P JL-500P1 JP-920P IF-19004 JO-900P JT-900P YN-901P TL-271T YG-211T IF-916P QP-038P TL-273T3 TL-220T 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 TG-900P QI-634P BR-903PA TL-062S AA-674P IF-917P JL-630P TL-274T3 IF-943P IF-955P BR-906PA YJ-671P TL-271T3 YG-122T QS-065PA SC-170R YP-712T QS-042P QI-631P YN-990P IF-954P YS-096P5 QF-907P YG-213T 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 CD-237P QI-320PA YP-714T MU-631RA WS-671P IF-948P QF-908P QF-902P YJ-672P IF-928P SB-170P RY-910PA YG-101T NK-ASPECT-BISX MU-671RA IF-937P JL-650P IF-944P TL-535U IF-925P IF-958P Nihon Kohden JE-120A Multi Electrode Junction Box 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 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 Nihon Kohden AE-918P Neuro Unit BM-412B JW-120B QP-039P Afib Detection Program CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T TG-101T TG-900P JG-900P YG-101T TL-061S SB-170P TG-980P DH-172P YS-100P7 YG-122T YG-272T TL-062S DH-171P TL-273T3 YG-213T TL-220T TL-052S TL-271T YG-111T TG-970P TL-274T TL-201T TL-274T3 TL-535U TL-272T TG-101T JG-900P JL-030U2 TL-273T KC-170P JL-500P1 TL-631T1 TL-271T3 HIT-100 JL-030U1 YG-242T TL-631T3 YG-214T YG-232T YG-227T TL-051S TG-920P YG-101T TG-900P YG-282T DH-380P YG-211T TL-272T3 BSM-2301A JP-900P YN-900P TL-274T TL-052S NK-ASAAPPLIANCE BR-906PA TG-900P YN-901P YN-920P YG-122T YN-990P JL-900P JP-910P BSM-2351A BR-916PA JG-900P TL-631T3 YG-111T TG-101T JC-906PA NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR TL-062S BSM-2354A YG-101T JP-920P TL-201T BR-913PA TL-271T BR-903PA YN-921P TL-220T CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 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 TL-631T3 A/NTX-DISP TL-272T3 ZM-530PA ZM-521PA TL-062S ZM-541PA TL-271T TL-274T YN-990P TL-273T3 BR-913PA ZS-940PA YP-504P ZM-520PA YP-944P A/NTX2-POUCH BR-916PA ZM-531PA TL-201T BR-906PA TL-271T3 TL-274T3 BR-903PA TL-052S ZM-540PA YP-503P YP-943P TL-220T TG-920P YG-135T YG-125T MEB-2300A Neuropack Evoked Potential & EMG Measuring System 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 QP-160AK BR-903PA TL-201T TL-052S JC-103TA YN-121T YN-990P TL-062S YN-101T BR-913PA 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 PSG-1100 Sleep Diagnostic System TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 Nihon Kohden TG-970 CO2 Sensor Kit TG-970P NK-NEUROFAX-R TL-062S JE-213A A/TRACKTRANS JE-120A-24 NK-CENTRAL-150 QP-160R-10 TG-921T3 QI-123A A/RELAYBOX TL-274T 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 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 JE-922A KE-122A TL-271T EEG-1200A TL-201T NK-LS-901AJ NK-XPPSGRD-SFF A/DCIN1200 A/QP-160A-VS-25 JE-120A-23 JL-550T1 TL-052S 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 TL-220T JE-227AK EEG-1200A-RAID EEG-1100A Switchbox JE-425A JE-215AK JE-208A LS-703AA JE-212A JE-207A QP-110AK NE-134A JE-217AK JE-912AK JE-209A JE-216AK KC-001A NE-090S1 ZElectrode NE-091S7 Disposable Electrode AE-120A EEG Heatset TL-201T JE-912AK TL-274T TL-062S TL-220T TL-052S JL-951T3 TL-271T Medical Device Gateway Communication Cable MDI-1000 IF-949P Nihon Kohden MS-120BK Electric Stimulator 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 QP-160AK EEG TREND PROGRAM PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A TG-921T3 JE-208A TL-273T LS-703A NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS QP-110AK JE-215AK A/POUCH-JE922 LS-703AA TL-274T JE-922A QI-120A TL-271T NE-134A TL-062S JE-217AK LS-901AJ YZ-0226 A/POUCHTRIFOLD JE-209A TL-220T TL-052S BC-112B JE-425A JE-207A NE-311A JE-216AK NC-143E QP-150AK JE-912AK JE-921A JL-550T1 EEG-9100A KC-001A TL-201T KE-910A JE-212A EEG-9200A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-11-18
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2007-11-28
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2007-11-28
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2007-11-28
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-11-28
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2007-11-28
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2007-11-28
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-06-13
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-03-26
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-01-13
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-08-30
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2017-08-30
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2015-03-16
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-03-16
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2015-03-16
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2008-10-08
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-04-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-10-18
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2017-10-18
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2019-07-11
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-11-28
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-12-16
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2007-10-31
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-02-11
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-09-20
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2012-09-20
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2012-09-20
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-09-20
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2012-09-20
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-09-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2021-07-21
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2017-05-22
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2017-05-22
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	Class 2	882.1400	2017-05-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2017-05-22
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2007-11-28
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2021-06-18
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-07
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2012-12-07
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-04-10
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2008-10-07
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2008-10-07
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-10-07
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2016-02-08
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2016-02-08
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-05-01
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-05-01
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-06-26
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2011-08-08
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-08
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-09-06
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2016-09-06
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2010-07-19
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2010-07-19
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2010-07-19
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-02
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-08-02
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Charlemagne Chua Business: NIHON KOHDEN AMERICA, LLC. Email: charlemagne_chua@nihonkohden.com Phone: (949) 3303964

Related Public Records

Same Entity

NIHON KOHDEN CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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3030516450	Nihon Vinyl Cord Corporation - Shimo-ongata Factory	Hachioji-shi Tokyo, JP
3007481893	Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center	Fukaya-Shi Saitama, JP

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Related Recall Records

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Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
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Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030229. Last updated year: 2026. Please use registration number 8030229 when referencing this establishment in official correspondence.