Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030154814

FEI Number

3030154814

Entity Name

Nihon Kohden America Fulfillment Center

City/State/Country

Foothill Ranch, CA, US

Establishment Address

20091 Ellipse, Suite 100, Foothill Ranch, CA 92610, US

Establishment Type(s)

Manufacture Medical 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

K051178

PMA Number

N/A

All Registered Proprietary Names

TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T TG-101T TG-900P JG-900P YG-101T 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-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 MULTIPLE PATIENT RECEIVER ORG-9700A YG-122T QP-101BK MEE-1000A NEUROMASTER

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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2007-10-31
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2007-11-28
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2007-11-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-28
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-11-28

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
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
3007962724	Nihon Kohden Tomioka Corporation	Gunma Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K862544	Suzuken Co., Ltd.	KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH	1986-08-06

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-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

Similar Registrations

Registration Number	Establishment Name	Location
3005733633	EPM GLOBAL SERVICES INC., DBA VEXOS	Markham Ontario, CA
3007389703	NOX MEDICAL	Reykjavik, IS
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US
3006125362	NEUROVIRTUAL USA, INC.	Fort Lauderdale, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030154814. Last updated year: 2026. Please use registration number 3030154814 when referencing this establishment in official correspondence.