FUKUDA DENSHI CO., LTD.

FDA Device Registration & Listing · SHIROI-City Tokyo, JP · Registration 3009607734

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009607734
FEI Number
3009607734
Entity Name
FUKUDA DENSHI CO., LTD.
City/State/Country
SHIROI-City Tokyo, JP
Establishment Address
305-1 NAKA, SHIROI-City Tokyo 270-1495, JP
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
K112521
PMA Number
N/A

All Registered Proprietary Names

Fukuda Denshi HG Series Pulse Oximeter Fukuda Denshi DS-7000 Monitor Fukuda Denshi LX-Series Telemetry Transmitter DynaScope DS-8000 Series Patient Monitors Fukuda Denshi CVW Series Data Management System CardiMax FX-8000/9000 Series ECG DynaScope DS-8100 Series Fukuda Denshi Central Station Series Monitor Fukuda Denshi VaSera 1000/2000 Series

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2008-01-16
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2009-01-06
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2009-12-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2015-03-26
OUG Medical Device Data System General Hospital Class 1 880.6310 2012-01-12
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2018-04-30
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2015-03-26
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2009-12-10
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

Official Correspondent

Doug Blakely

US Agent Details

Doug Blakely Business: Fukuda Denshi USA, Inc. Email: DBlakely@FukudaAmerica.com Phone: (210) 2404521

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
3031158 FUKUDA DENSHI USA, INC. REDMOND, WA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009607734. Last updated year: 2026. Please use registration number 3009607734 when referencing this establishment in official correspondence.
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