The following data is part of a premarket notification filed by Visus Technology Transfer Gmbh with the FDA for Jivex.
Device ID | K162008 |
510k Number | K162008 |
Device Name: | JiveX |
Classification | System, Image Processing, Radiological |
Applicant | VISUS TECHNOLOGY TRANSFER GMBH Universitaetsstrasse 136 Bochum, DE 44799 |
Contact | Axel Schreiber |
Correspondent | Axel Schreiber VISUS TECHNOLOGY TRANSFER GMBH Universitaetsstrasse 136 Bochum, DE 44799 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-20 |
Decision Date | 2016-09-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
JIVEX 76318064 2876014 Live/Registered |
VISUS HEALTH IT GMBH 2001-09-27 |