Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031158

FEI Number

3000215024

Entity Name

FUKUDA DENSHI USA, INC.

City/State/Country

REDMOND, WA, US

Establishment Address

17725 N.E. 65TH ST., BLDG. C, REDMOND, WA 98052, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

FUKUDA DENSHI CO., LTD. (Owner Number: 9028352)

Owner / Operator Contact Address

3-39-4, HONGO, BUNKYO-KO, --, TOKYO, JP-NOTA 113, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081919

PMA Number

N/A

All Registered Proprietary Names

Fukuda Denshi 4000 Series ECG Fukuda Denshi DSX Series Telemetry Transmitter Fukuda Denshi LX-Series Telemetry Transmitter Fukuda Denshi VaSera 1000/2000 Series CardiMax FX-8000/9000 Series ECG DynaScope DS-5000 Series Central Station FD DS-5000 Series Telemetry FD DS-7100 Series Patient Monitor FD UF-750 3D Ultrasound Fukuda Denshi US-750 XT Ultrasound Fukuda Denshi 5000 Series Telemetry Transmitter FD DMS Software Fukuda Denshi DS-7000 Monitor Fukuda Denshi UF-Series Ultrasound Fukuda Denshi CVW Series Data Management System DynaScope DS-8100 Series Sigma 5000 Series Ultrasound Fukuda Denshi UltraSound UF-760AG Fukuda Denshi DynaScope 7000 Series Patient Monito Fukuda Denshi FCP Series ECG Fukuda Denshi HG Series Pulse Oximeter Fukuda Denshi UF-800 Series Ultrasound

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOS	N/A	N/A	Class N/A	N/A	2008-01-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-03-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-01-06
JOO	Transducer, Heart Sound	Cardiovascular	Class 2	870.2860	2012-01-06
DQC	Phonocardiograph	Cardiovascular	Class 1	870.2390	2012-01-06
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2018-04-30
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2008-01-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-01-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-01-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2008-01-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-01-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-01-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2008-01-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-01-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-01-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-01-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-01-06
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2009-06-08
NSX	N/A	N/A	Class N/A	N/A	2008-05-23
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-01-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-08-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-08-25
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2012-01-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-03-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2008-01-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-01-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-01-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-04-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-04-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-04-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-12-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-12-10
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2009-12-10
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2009-12-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-12-10
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2009-12-10
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2009-12-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-12-10
LOS	N/A	N/A	Class N/A	N/A	2009-02-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-01-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-01-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-01-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUKUDA DENSHI CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611031	FUKUDA DENSHI CO., LTD.	BUNKYO-KU Tokyo, JP
3010663777	Fukuda Denshi Fine Tech Sendai Co. Ltd.	Kurokawa-gun Miyagi, JP
3009607734	FUKUDA DENSHI CO., LTD.	SHIROI-City 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031158. Last updated year: 2026. Please use registration number 3031158 when referencing this establishment in official correspondence.