FUKUDA DENSHI
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
FUKUDA DENSHI USA, INC.
The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi.
Pre-market Notification Details
| Device ID | K103134 |
| 510k Number | K103134 |
| Device Name: | FUKUDA DENSHI |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | Doug Blakely |
| Correspondent | Doug Blakely FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-03-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612911064 | K103134 | 000 |
| 04538612910418 | K103134 | 000 |
| 04538612910425 | K103134 | 000 |
| 04538612915758 | K103134 | 000 |
| 04538612914683 | K103134 | 000 |
| 04538612914690 | K103134 | 000 |
| 04538612914256 | K103134 | 000 |
| 04538612914263 | K103134 | 000 |
| 04538612914188 | K103134 | 000 |
| 04538612914195 | K103134 | 000 |
| 04538612914454 | K103134 | 000 |
| 04538612914591 | K103134 | 000 |
| 04538612914607 | K103134 | 000 |
| 04538612907760 | K103134 | 000 |
| 04538612908590 | K103134 | 000 |
| 04538612908606 | K103134 | 000 |
| 04538612908613 | K103134 | 000 |
| 04538612910401 | K103134 | 000 |
Trademark Results [FUKUDA DENSHI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FUKUDA DENSHI 75500255 2346482 Live/Registered |
FUKUDA DENSHI CO., LTD. 1998-06-11 |
 FUKUDA DENSHI 73433851 1351395 Dead/Cancelled |
FUKUDA DENSHI KABUSHIKI KAISHA 1983-07-11 |
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