The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Digital Lightbox.
Device ID | K080608 |
510k Number | K080608 |
Device Name: | DIGITAL LIGHTBOX |
Classification | System, Image Processing, Radiological |
Applicant | BRAINLAB, AG KAPELLENSTR. 12 Feldkirchen, DE 85622 |
Contact | Rainer Birkenbach |
Correspondent | Rainer Birkenbach BRAINLAB, AG KAPELLENSTR. 12 Feldkirchen, DE 85622 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-04 |
Decision Date | 2008-04-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIGITAL LIGHTBOX 77332451 3972062 Dead/Cancelled |
BrainLAB AG 2007-11-18 |