Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030516450

FEI Number

3030516450

Entity Name

Nihon Vinyl Cord Corporation - Shimo-ongata Factory

City/State/Country

Hachioji-shi Tokyo, JP

Establishment Address

424-6 Shimo-ongata-machi, Hachioji-shi Tokyo 192-0154, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-12-28

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
3007481893	Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center	Fukaya-Shi Saitama, JP
3007962724	Nihon Kohden Tomioka Corporation	Gunma Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

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

Similar Registrations

Registration Number	Establishment Name	Location
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL
3012972516	Defibtech Branford	Branford, CT, US
3005877899	METROPOLIS INTERNATIONAL, LLC	Long Island City, NY, US
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030516450. Last updated year: 2026. Please use registration number 3030516450 when referencing this establishment in official correspondence.