The following data is part of a premarket notification filed by Softneta Uab with the FDA for Meddream.
| Device ID | K162011 |
| 510k Number | K162011 |
| Device Name: | MedDream |
| Classification | System, Image Processing, Radiological |
| Applicant | SOFTNETA UAB K.BARAUSKO STR. 59 Kaunas, LT 51423 |
| Contact | Laura Baroniene |
| Correspondent | Raymond Kelly LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-21 |
| Decision Date | 2016-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04779049590105 | K162011 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDDREAM 79162201 4872460 Live/Registered |
UAB "Softneta" 2014-12-19 |