Device Classification Name |
Stimulator, Electrical, Evoked Response
|
510(k) Number |
K965065 |
Device Name |
TECA. MILLENNIUM |
Applicant |
MEDELEC LTD. |
MANOR WAY |
OLD WOKING |
SURREY, ENGLAND GU22 9JU,
GB
|
|
Applicant Contact |
JEFF HALL |
Correspondent |
MEDELEC LTD. |
MANOR WAY |
OLD WOKING |
SURREY, ENGLAND GU22 9JU,
GB
|
|
Correspondent Contact |
JEFF HALL |
Regulation Number | 882.1870
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/18/1996 |
Decision Date | 06/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|