ADAS 3D
System, Image Processing, Radiological
Galgo Medical S.L
The following data is part of a premarket notification filed by Galgo Medical S.l with the FDA for Adas 3d.
Pre-market Notification Details
| Device ID | K191125 |
| 510k Number | K191125 |
| Device Name: | ADAS 3D |
| Classification | System, Image Processing, Radiological |
| Applicant | Galgo Medical S.L C/Comte D'Urgell, 143, 4B Barcelona, ES 08036 |
| Contact | Antoni Riu |
| Correspondent | Antoni Riu Galgo Medical S.L C/Comte D'Urgell, 143, 4B Barcelona, ES 08036 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2020-01-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437021722048 | K191125 | 000 |
Trademark Results [ADAS 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADAS 3D 79290357 not registered Live/Pending |
ADAS3D MEDICAL S.L. 2020-06-15 |
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