DDRELEMENT
System, X-ray, Stationary
SWISSRAY MEDICAL AG
The following data is part of a premarket notification filed by Swissray Medical Ag with the FDA for Ddrelement.
Pre-market Notification Details
| Device ID | K110828 |
| 510k Number | K110828 |
| Device Name: | DDRELEMENT |
| Classification | System, X-ray, Stationary |
| Applicant | SWISSRAY MEDICAL AG ONE TOWER CENTER East Brunswick, NJ 07201 |
| Contact | John Monahan |
| Correspondent | John Monahan SWISSRAY MEDICAL AG ONE TOWER CENTER East Brunswick, NJ 07201 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-24 |
| Decision Date | 2011-08-23 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011334613 | K110828 | 000 |
Trademark Results [DDRELEMENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DDRELEMENT 86796060 5085066 Live/Registered |
Swissray Global Healthcare Holding Limited 2015-10-22 |
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