Device Classification Name |
Electrode, Cortical
|
510(k) Number |
K201931 |
Device Name |
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) |
Applicant |
Dixi Medical |
2A Route de Pouligney |
Chaudefontaine,
FR
25640
|
|
Applicant Contact |
Lucie Petegnief |
Correspondent |
Domecus Consulting Services LLC |
1171 Barroilhet Drive |
Hillsborough,
CA
94010
|
|
Correspondent Contact |
Cindy Domecus |
Regulation Number | 882.1310
|
Classification Product Code |
|
Date Received | 07/13/2020 |
Decision Date | 10/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|