Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K142159 |
Device Name |
DISPOSABLE PRE-GELLED SURFACE ELECTRODE |
Applicant |
ROCHESTER ELECTRO MEDICAL, INC. |
19404 PINE VALLEY DRIVE |
ODESSA,
FL
33556
|
|
Applicant Contact |
WAYNE GLOVER |
Correspondent |
ROCHESTER ELECTRO MEDICAL, INC. |
19404 PINE VALLEY DRIVE |
ODESSA,
FL
33556
|
|
Correspondent Contact |
WAYNE GLOVER |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 08/06/2014 |
Decision Date | 06/03/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|