Device Classification Name |
Media, Electroconductive
|
510(k) Number |
K212326 |
Device Name |
AC Cream - Conductive paste |
Applicant |
Spes Medica S.r.l |
Via Europa-Zona industriale |
Battipaglia,
IT
84091
|
|
Applicant Contact |
Giorgio Facco |
Correspondent |
Spes Medica S.r.l |
Via Europa-Zona industriale |
Battipaglia,
IT
84091
|
|
Correspondent Contact |
Giorgio Facco |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 07/26/2021 |
Decision Date | 12/01/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|