Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2080783

FEI Number

2080783

Entity Name

NIHON KOHDEN AMERICA, INC.

City/State/Country

Irvine, CA, US

Establishment Address

15353 Barranca Pkwy, Irvine, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

N/A

PMA Number

N/A

All Registered 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 TL-201T TL-052S JC-103TA YN-121T YN-990P TL-062S YN-101T BR-913PA 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 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 CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 BLUPRO Attachment Tape YS-111P7 (P263A) BLUPRO Attachment Tape, YS-111P7 YG-122T TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 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 Nihon Kohden QP-160AK EEG Trend Program CD-237P NE-090S1 ZElectrode NE-091S7 Disposable Electrode AE-120A EEG Heatset 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 SKIN PURE EMG ELECTRODES AND EXTENSION CORDS Nihon Kohden AE-918P Neuro Unit Nihon Kohden MS-120BK Electric Stimulator QP-039P Afib Detection Program LS-703A ELECTRODE/LEAD 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 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 TG-980P TG-970P TG-980P1 Nihon Kohden TG-970 CO2 Sensor Kit TG-970P 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 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-213T YG-235T YG-214T YG-213T-A1 YG-225T YG-211T 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 P-Blade ITL-LL Airway Scope AWS-S200 P-Blade ITL-NL P-Blade ITL-PL P-Blade ITL-SL P-Blade ITL-TL 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 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 TG-900P YG-101T TG-101T JG-900P MULTIPLE PATIENT RECEIVER ORG-9700A 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 TL-631T1 JS-210B JS-201B TL-260T JB-210B BM-121B NE-114A JL-550T1 TL-220T YG-135T TG-921T3 QI-120A MEE-2000A-DT QP-101BK DC-200B Neural Function Measuring System MEE-2000 YB-201B TL-631T3 Neuromaster G1 MEE-2000 TL-201T TL-062S NE-113A JS-202B BM-701B TL-052S YE-103J TL-051S JB-316B JB-232B JS-204B LS-102J YG-122T A/NWB-HL7CS TL-061S YG-125T NE-134A VD-403B MEE-2000A-LT DR-531B-14 JS-203B P225F ORG-9100A QP-160AK Medical Device Gateway Communication Cable MDI-1000 IF-949P

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
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-05-30
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-08-20
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2007-11-28
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2007-11-28
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2007-11-28
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
HXB	Probe	Orthopedic	Class 1	888.4540	2008-06-11
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2007-11-28
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-12-28
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
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-12-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-06-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
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
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	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
KGK	Gas, Collecting Vessel	Anesthesiology	Class 1	868.1575	2008-09-12
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-05-01
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-05-01
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
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2007-11-28
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	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
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2011-08-08
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-08
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-04-29
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2008-04-29
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	2017-04-11
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2017-04-11
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2020-03-19
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	2017-03-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-04-10
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
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	Class 1	862.2050	2008-06-11
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
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-18
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
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-12-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-06-13
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-01-13
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
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-02
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-08-02
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2007-11-28
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2007-11-28
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-04-29
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-04-28
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2008-06-11
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
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-06-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11
K113105	Remote Diagnostic Technologies , Ltd.	TEMPUSIC PATIENT MONITOR	2011-12-15

Related Recall Records

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Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2080783. Last updated year: 2026. Please use registration number 2080783 when referencing this establishment in official correspondence.