Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016852448

FEI Number

3016852448

Entity Name

Nihon Kohden Corporation - Eastern Japan Logistics Center

City/State/Country

Sakado City Saitama, JP

Establishment Address

1-1 Nishi-Inter, 2-Chome, Sakado City Saitama 350-0259, JP

Establishment Type(s)

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

K011918

PMA Number

N/A

All Registered 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 TG-101T TG-900P JG-900P YG-101T P225F Nihon Kohden TG-970 CO2 Sensor Kit TG-970P LS-703A TG-980P TG-970P TG-980P1 BR-903PA TL-201T TL-052S JC-103TA YN-121T YN-990P TL-062S 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-980P TG-980P1 CO2 Sensor Kit with Smart Cable TG-980P1 CO2 Sensor Kit TG-980P1 TG-980P CO2 Sensor Kit with Smart Cable MEB-2300A Neuropack Evoked Potential & EMG Measuring System SKIN PURE KH-001A GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors Nihon Kohden MS-120BK Electric Stimulator 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 ANALYZER 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 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 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 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 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 TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 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 IF-920P YJ-671P IF-950P QF-921P JT-900P QF-908P IF-925P YG-211T LIFE SCOPE® G9 TL-220T 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 TL-201T YN-990P 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-062S 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 TL-274T G9-KVM/ZA TL-052S 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 TL-271T YS-108P2 QF-901P YG-213T IF-951P YS-106P3 BR-903PA YS-106P7 JC-906PA IF-917P IF-913P YP-810P JT-950P TL-535U YN-925P 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 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 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 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 Life Scope® PT BSM-1700 Series 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2012-03-26
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2012-03-26
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2012-03-26
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2021-06-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-05-30
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-02
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-08-02
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2007-10-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-04-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-04-10
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2008-04-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-03-13
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-08-20
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
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2007-11-28
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2008-04-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-11-18
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2011-08-08
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-08
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
BXA	Analyzer, Gas, Water Vapor, Gaseous-Phase	Anesthesiology	Class 1	868.1975	2007-12-28
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
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
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2007-11-28
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
KGK	Gas, Collecting Vessel	Anesthesiology	Class 1	868.1575	2008-09-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-12-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-06-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-08-15
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-08-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2021-07-21
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
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2008-06-11
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-03-26
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-02-11
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2007-11-28
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-20
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2023-09-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-09-20
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-09-20
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2019-07-11
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
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2008-09-12
GYA	Tester, Electrode/Lead, Electroencephalograph	Neurology	Class 1	882.1410	2008-01-29
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-12-28
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-04-11
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2017-04-11
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2007-11-28
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
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
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-05-01
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-05-01
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-01-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	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 →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021736577	Nihon Vinyl Cord Corporation - Kodama Second Factory	Honjo-shi Saitama, JP
3030154814	Nihon Kohden America Fulfillment Center	Foothill Ranch, CA, US
2032233	Nihon Kohden Digital Health Solutions, LLC.	IRVINE, CA, US
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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Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016852448. Last updated year: 2026. Please use registration number 3016852448 when referencing this establishment in official correspondence.