Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K092467 |
FOIA Releasable 510(k) |
K092467
|
Device Name |
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED |
Applicant |
BRAINLAB AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Applicant Contact |
ALEXANDER DRUSE |
Correspondent |
BRAINLAB AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Correspondent Contact |
ALEXANDER DRUSE |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 08/12/2009 |
Decision Date | 05/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|