The following data is part of a premarket notification filed by Visus Health It Gmbh with the FDA for Jivex.
Device ID | K181964 |
510k Number | K181964 |
Device Name: | JiveX |
Classification | System, Image Processing, Radiological |
Applicant | Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum, DE 44801 |
Contact | Axel Schreiber |
Correspondent | Axel Schreiber Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum, DE 44801 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-23 |
Decision Date | 2018-10-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
JIVEX 76318064 2876014 Live/Registered |
VISUS HEALTH IT GMBH 2001-09-27 |