Device Classification Name |
full-montage standard electroencephalograph
|
510(k) Number |
K964280 |
Device Name |
DG NERVUS |
Applicant |
MEDELEC LTD. |
MANOR WAY |
OLD WOKING, SURREY,
DE
GU22 9JU
|
|
Applicant Contact |
CAROL BLEAKLEY |
Correspondent |
MEDELEC LTD. |
MANOR WAY |
OLD WOKING, SURREY,
DE
GU22 9JU
|
|
Correspondent Contact |
CAROL BLEAKLEY |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 10/28/1996 |
Decision Date | 01/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|