Data / Medical devices / Japan / Fukuda Denshi Co., Ltd.
Fukuda Denshi Co., Ltd.: FDA-registered device maker in Shiroi-shi Chiba, Japan, 12 510(k) clearances
Fukuda Denshi Co., Ltd. is registered with the FDA (registration 3009607734) in Shiroi-shi Chiba, Japan. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 16, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009607734
- Address
- 305-1 Naka, Shiroi-shi Chiba, Japan, 270-1495
- Owner or operator
- Fukuda Denshi Co., Ltd. (9028352)
- Roles
- Manufacturer
- First device listed
- January 16, 2008
- Registered through
- 2026
- Brand names listed
- CardiMax FX-8000/9000 Series ECG, DYNASCOPE 2000 Series BDS-2100 System, DynaScope DS-8000 Series Patient Monitors, DynaScope DS-8100 Series, FD DS-7100 Series Patient Monitor, FD DS-7141 Series Monitor, Fukuda Denshi CVW Series Data Management System, Fukuda Denshi Central Station Series Monitor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Phonocardiograph | DQC | 1 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Heart Sound | JOO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2018 | K173226 | CardiMax Electrocardiograph | DPS | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| March 16, 2015 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| February 12, 2015 | K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| December 21, 2011 | K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 | DXN | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| March 11, 2011 | K103134 | FUKUDA DENSHI | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| March 19, 2009 | K083697 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| August 29, 2008 | K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| May 26, 2004 | K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| October 10, 2003 | K032290 | FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR | MHX | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| December 20, 2001 | K013273 | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE | DQA | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| September 9, 1997 | K970585 | FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR | DSI | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| May 1, 1997 | K964187 | FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR | DSI | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Oximeter
- All makers of Computer, Blood-Pressure
Updated April 16, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.