Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K120494 |
Device Name |
DISPOSABLE ADHESIVE SURFACE ELECTRODE |
Applicant |
SPES MEDICA S.R.L. |
VIA EUROPA-ZONA INDUSTRIALE |
BATTIPAGLIA,
IT
84091
|
|
Applicant Contact |
ALFREDO SPADAVECHIA |
Correspondent |
SPES MEDICA S.R.L. |
VIA EUROPA-ZONA INDUSTRIALE |
BATTIPAGLIA,
IT
84091
|
|
Correspondent Contact |
ALFREDO SPADAVECHIA |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 02/17/2012 |
Decision Date | 06/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|