| Device Classification Name |
Device, Galvanic Skin Response Measurement
|
| 510(k) Number |
K020567 |
| Device Name |
AKUPORT M1 |
| Applicant |
| Vibrant Health |
| 150 Des Grands Coteaux |
|
Beoeil, Quebec,
CA
J3G 2C9
|
|
| Applicant Contact |
STEPHEN EMOND |
| Correspondent |
| Vibrant Health |
| 150 Des Grands Coteaux |
|
Beoeil, Quebec,
CA
J3G 2C9
|
|
| Correspondent Contact |
STEPHEN EMOND |
| Regulation Number | 882.1540 |
| Classification Product Code |
|
| Date Received | 02/20/2002 |
| Decision Date | 05/02/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|