Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013501110

FEI Number

3013501110

Entity Name

Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center

City/State/Country

Tokorozawa Saitama, JP

Establishment Address

1-1-6 Kusunokidai, Tokorozawa-Shi, Saitama, Tokorozawa Saitama 359-0037, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

K163644

PMA Number

N/A

All Registered Proprietary Names

MEB-2300A Neuropack Evoked Potential & EMG Measuring System 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 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 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 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 EMG ELECTRODES AND EXTENSION CORDS Probe ORG-9100A Probe TL-630T3 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 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 BM-412B JW-120B SKIN PURE 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 AG-920RA AG-920RA Mulitgas Unit TG-900P YG-101T TG-101T JG-900P TG-980P TG-970P TG-980P1 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-201T JE-912AK TL-274T TL-062S TL-220T TL-052S JL-951T3 TL-271T CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T TG-101T TG-900P JG-900P YG-101T GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors BLUPRO Attachment Tape YS-111P7 (P263A) BLUPRO Attachment Tape, YS-111P7 QP-101BK MEE-1000A NEUROMASTER Nihon Kohden AE-918P Neuro Unit MULTIPLE PATIENT RECEIVER ORG-9700A 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-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 LS-703A PSG-1100 Sleep Diagnostic System Nihon Kohden QP-160AK EEG Trend Program TG-920P YG-135T YG-125T 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 QP-039P Afib Detection Program ANALYZER P225F Medical Device Gateway Communication Cable MDI-1000 IF-949P 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 YG-122T CD-237P TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 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 CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 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 ELECTRODE/LEAD QP-160AK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2016-09-06
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2016-09-06
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-08-20
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
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-11-28
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2007-11-28
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2008-09-12
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2008-06-11
HXB	Probe	Orthopedic	Class 1	888.4540	2008-06-11
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-04-29
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
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2008-10-08
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2007-11-28
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-06-13
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
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	2017-03-13
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2007-10-31
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	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-11-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-06-05
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2007-11-28
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	Class 1	862.2050	2008-06-11
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
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2008-04-29
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2020-03-19
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
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-02-11
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
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-04-29
BXA	Analyzer, Gas, Water Vapor, Gaseous-Phase	Anesthesiology	Class 1	868.1975	2007-12-28
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-04-28
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-06-26
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
KGK	Gas, Collecting Vessel	Anesthesiology	Class 1	868.1575	2008-09-12
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
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	2010-12-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-12-28
GYA	Tester, Electrode/Lead, Electroencephalograph	Neurology	Class 1	882.1410	2008-01-29
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

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

Similar Registrations

Registration Number	Establishment Name	Location
3018708317	MAGNUS MEDICAL INC.	Burlingame, CA, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
3008773490	PAUL E. DANCHELL A/S	Jyderup Sjalland, DK
9611252	NIHON KOHDEN CORP.	SHINJUKU-KU Tokyo, JP
3009959868	Ferry Machine Corporation	Little Ferry, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013501110. Last updated year: 2026. Please use registration number 3013501110 when referencing this establishment in official correspondence.