The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Navivision.
Device ID | K062086 |
510k Number | K062086 |
Device Name: | NAVIVISION |
Classification | Neurological Stereotaxic Instrument |
Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
Contact | Rainer Birkenbach |
Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-21 |
Decision Date | 2006-09-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NAVIVISION 79023728 3436168 Dead/Cancelled |
Brainlab AG 2006-03-16 |