Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611252

FEI Number

3002807720

Entity Name

NIHON KOHDEN CORP.

City/State/Country

SHINJUKU-KU Tokyo, JP

Establishment Address

31-4 NISHIOCHIAI, 1-CHOME,, SHINJUKU-KU Tokyo 161-8560, JP

Establishment Type(s)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

MULTIPLE PATIENT RECEIVER ORG-9700A QP-160AK BM-412B JW-120B KH-001A CD-237P 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 CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P 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 AG-920RA AG-920RA Mulitgas Unit Probe TL-630T3 Nihon Kohden AE-918P Neuro Unit QP-039P Afib Detection Program SKIN PURE P225F CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T TG-101T TG-900P JG-900P YG-101T TG-980P TG-970P TG-980P1 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 ORG-9100A QP-160AK EEG TREND PROGRAM YG-122T 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 TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 Probe 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 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 TL-201T JE-912AK TL-274T TL-062S TL-220T TL-052S JL-951T3 TL-271T TG-920P YG-135T YG-125T Electrode H072 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 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 EMG ELECTRODES AND EXTENSION CORDS Nihon Kohden TG-970P Sensor Kit w/ Airway Adapter YG-213T YG-213T 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 EEG-1100A Switchbox 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 BR-903PA TL-201T TL-052S JC-103TA YN-121T YN-990P TL-062S YN-101T BR-913PA TG-900P YG-101T TG-101T JG-900P ANALYZER Decoration parts Nihon Kohden MS-120BK Electric Stimulator PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A 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 Nihon Kohden TG-970 CO2 Sensor Kit TG-970P PSG-1100 Sleep Diagnostic System Nihon Kohden JE-120A Multi Electrode Junction Box 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 ELECTRODE/LEAD Medical Device Gateway Communication Cable MDI-1000 IF-949P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	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
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2008-10-08
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2008-04-29
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	2017-04-11
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2017-04-11
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
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	2007-11-28
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
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
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-04-29
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	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	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-03-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2021-07-21
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2008-06-11
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
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	2025-08-20
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
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2008-09-12
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2019-07-11
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
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
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	2008-02-11
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	2007-11-28
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-11-28
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-18
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-05-30
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-04-29
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
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2021-06-18
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	2007-11-28
BXA	Analyzer, Gas, Water Vapor, Gaseous-Phase	Anesthesiology	Class 1	868.1975	2007-12-28
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2008-04-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2011-08-08
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-08
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2011-08-02
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-08-02
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	2009-04-10
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
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-03-26
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
GYA	Tester, Electrode/Lead, Electroencephalograph	Neurology	Class 1	882.1410	2008-01-29
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-06-26

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

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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
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611252. Last updated year: 2026. Please use registration number 9611252 when referencing this establishment in official correspondence.