The following data is part of a premarket notification filed by Galgo Medical S.l with the FDA for Adas 3d.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08437021722048 | K191125 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ADAS 3D 79290357 not registered Live/Pending |
ADAS3D MEDICAL S.L. 2020-06-15 |