FDA Registration
Active
🇯🇵 Japan
FUKUDA DENSHI CO., LTD.
Reg #: 3009607734
·
FEI: 3009607734
·
Expires 2026
Products
13
Proprietary Names
13
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- FUKUDA DENSHI CO., LTD.
- Registration Number
- 3009607734
- FEI Number
- 3009607734
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 305-1 NAKA
- City
- SHIROI-City Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K013273
Owner / Operator
- Firm Name
- FUKUDA DENSHI CO., LTD.
- Operator Number
- 9028352
- Address
- 3-39-4, HONGO, BUNKYO-KO, --
- City
- TOKYO
- State
- JP-NOTA
- Postal Code
- 113
- Country
- JP
- Correspondent
- Doug W Blakely
US Agent
- Business Name
- Fukuda Denshi USA, Inc.
- Contact Name
- Doug Blakely
- Address
- 17725 Ne 65th St Ste C
- City
- Redmond
- State
- WA
- ZIP
- 98052
- Country
- US
- [email protected]
- Phone
- 210 2404521
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2008-01-16 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2009-01-06 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2009-12-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2012-01-12 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2018-04-30 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-01-06 |
| Transducer, Heart Sound | JOO | Class 2 | Cardiovascular | No | 2012-01-06 |
| Phonocardiograph | DQC | Class 1 | Cardiovascular | No | 2012-01-06 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2009-12-10 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2009-12-10 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2009-12-10 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2009-12-10 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2009-12-10 |
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
Fukuda Denshi DSX Series Telemetry Transmitter
FD DS-7141 Series Monitor
FD DS-7100 Series Patient Monitor
Fukuda Denshi DynaScope 7000 Series Patient Monito
Establishment Types
Manufacture Medical Device