FUKUDA DENSHI
GUDID 04538612913433
FUKUDA DENSHI CO.,LTD.
Electrocardiographic lead set, reusable| Primary Device ID | 04538612913433 |
| NIH Device Record Key | 47d0c1d3-1ca7-4d35-993f-79595fbfd7bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FUKUDA DENSHI |
| Version Model Number | CMF-700-5CFA |
| Company DUNS | 690671011 |
| Company Name | FUKUDA DENSHI CO.,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04538612913433 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083697
FDA Product Code
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-25 |
On-Brand Devices [FUKUDA DENSHI]
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.