Device Classification Name |
Device, Galvanic Skin Response Measurement
|
510(k) Number |
K020564 |
Device Name |
EAV KINDLING 2000S GSR DEVICE |
Applicant |
VIRBRANT HEALTH |
150 DES GRANDS COTEAUX |
BELOEIL, QUEBEC,
CA
J3G 2C9
|
|
Applicant Contact |
STEPHEN EMOND |
Correspondent |
VIRBRANT HEALTH |
150 DES GRANDS COTEAUX |
BELOEIL, QUEBEC,
CA
J3G 2C9
|
|
Correspondent Contact |
STEPHEN EMOND |
Regulation Number | 882.1540
|
Classification Product Code |
|
Date Received | 02/20/2002 |
Decision Date | 04/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|