The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Vectorvision Hip.
Device ID | K060468 |
510k Number | K060468 |
Device Name: | VECTORVISION HIP |
Classification | Neurological Stereotaxic Instrument |
Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
Contact | Rainer Birkenbach |
Correspondent | Rainer Birkenbach BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-23 |
Decision Date | 2006-03-20 |
Summary: | summary |