Device Classification Name |
electrode, cortical
|
510(k) Number |
K173684 |
Device Name |
g.Estim PRO |
Applicant |
g.tec medical engineering GmbH |
Siemingerstrasse 14 |
schiedlberg,
AU
4521
|
|
Applicant Contact |
christoph guger |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
new brighton,
MN
55112 -1891
|
|
Correspondent Contact |
olaf teichert |
Regulation Number | 882.1310
|
Classification Product Code |
|
Date Received | 12/01/2017 |
Decision Date | 05/04/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|