Device Classification Name |
Electrode, Cortical
|
510(k) Number |
K211954 |
Device Name |
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid |
Applicant |
Spes Medica SRL |
Via Europa -Zona Industriale |
Battipaglia,
IT
84091
|
|
Applicant Contact |
Giorgio Facco |
Correspondent |
Spes Medica SRL |
Via Europa - Zona Industriale |
Battipaglia,
IT
84091
|
|
Correspondent Contact |
Giorgio Facco |
Regulation Number | 882.1310
|
Classification Product Code |
|
Date Received | 06/23/2021 |
Decision Date | 11/10/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|