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 |