Data / Medical devices / Japan / Fukuda Denshi Co., Ltd.
Fukuda Denshi Co., Ltd.: FDA-registered device maker in Bunkyo-ku Tokyo, Japan, 18 510(k) clearances
Fukuda Denshi Co., Ltd. is registered with the FDA (registration 9611031) in Bunkyo-ku Tokyo, Japan. It lists 15 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 16, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611031
- FEI number
- 3002807019
- Address
- 3-39-4 Hongo, Bunkyo-ku Tokyo, Japan, 113-8483
- Owner or operator
- Fukuda Denshi Co., Ltd. (9028352)
- Roles
- Specification developer
- 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-5000 Series Central Station, DynaScope DS-8000 Series Patient Monitors, DynaScope DS-8100 Series, FD DMS Software, FD DS-5000 CS, FD DS-5700 CS and more
Devices it lists
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 |
| June 3, 2004 | K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM | 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 |
| February 6, 2002 | K020084 | FUKUDA DENSHI DYNASCOPE MODEL DS-5700 | DSI | 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 |
| April 7, 2000 | K000746 | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX | DSI | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| August 31, 1998 | K981066 | FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| June 19, 1998 | K980728 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM | DSI | Substantially Equivalent | Fukuda Denshi USA, Inc. | accessdata.fda.gov |
| December 2, 1997 | K971440 | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH | LOS | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 16, 2017 | 78441 | Class II | Completed | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the fo | For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup). | accessdata.fda.gov |
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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.