Device Classification Name |
electrode, cortical
|
510(k) Number |
K221123 |
Device Name |
WISE Cortical Strip (WCS) |
Applicant |
WISE S.r.l. |
Via Michelangelo Buonarroti ,38 |
Cologno Monzese,
IT
20093
|
|
Applicant Contact |
Luca Ravagnan |
Correspondent |
Decus Biomedical |
2342 Shattuck Ave #333 |
Berkeley,
CA
94704
|
|
Correspondent Contact |
Terri Bogucki |
Regulation Number | 882.1310
|
Classification Product Code |
|
Date Received | 04/18/2022 |
Decision Date | 11/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|