Device Classification Name |
Device, Galvanic Skin Response Measurement
|
510(k) Number |
K970436 |
Device Name |
E-READER |
Applicant |
NATURAL HERBAL PRODUCTS, INC. |
724 WIGGINS BAY DR. |
NAPLES,
FL
34110
|
|
Correspondent |
NATURAL HERBAL PRODUCTS, INC. |
724 WIGGINS BAY DR. |
NAPLES,
FL
34110
|
|
Regulation Number | 882.1540
|
Classification Product Code |
|
Date Received | 02/05/1997 |
Decision Date | 08/15/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|