Device Classification Name |
Automatic Event Detection Software For Full-Montage Electroencephalograph
|
510(k) Number |
K002332 |
Device Name |
EEG SPIKE AND EVENT DETECTOR MODULE |
Applicant |
EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE |
OAKVILLE, ONTARIO,
CA
L6H 5S1
|
|
Applicant Contact |
DEBBIE DAVY |
Correspondent |
EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE |
OAKVILLE, ONTARIO,
CA
L6H 5S1
|
|
Correspondent Contact |
DEBBIE DAVY |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 08/01/2000 |
Decision Date | 10/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|