The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Vv Fluoro 3d.
Device ID | K070106 |
510k Number | K070106 |
Device Name: | VV FLUORO 3D |
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 | 2007-01-11 |
Decision Date | 2007-04-23 |
Summary: | summary |