Device Classification Name |
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
|
510(k) Number |
K172858 |
Device Name |
PreOp |
Applicant |
Epilog |
Vlasgaardstraat 52 |
Ghent,
BE
9000
|
|
Applicant Contact |
Gregor Strobbe |
Correspondent |
Qserve Group US Inc. |
5600 Wisconsin Avenue |
Chevy Chase,
MD
20815
|
|
Correspondent Contact |
Patsy Trisler |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 09/20/2017 |
Decision Date | 01/08/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|