Device Classification Name |
device, galvanic skin response measurement
|
510(k) Number |
K032935 |
Device Name |
EPI-SCAN, MODEL P 100 |
Applicant |
EDX EPI-SCAN, INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GREG HOLLAND |
Correspondent |
EDX EPI-SCAN, INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GREG HOLLAND |
Regulation Number | 882.1540
|
Classification Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 11/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|