Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K023651 |
Device Name |
VECTORVISION CRANIAL/ENT |
Applicant |
BRAINLAB AG |
AMMERTHALSTRASSE 8 |
HEIMSTETTEN,
DE
85551
|
|
Applicant Contact |
RAINER BIRKENBACH |
Correspondent |
BRAINLAB AG |
AMMERTHALSTRASSE 8 |
HEIMSTETTEN,
DE
85551
|
|
Correspondent Contact |
RAINER BIRKENBACH |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 10/30/2002 |
Decision Date | 02/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|