Device Classification Name |
stimulator, electrical, evoked response
|
510(k) Number |
K051864 |
Device Name |
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 |
Applicant |
THE MAGSTIM COMPANY LTD. |
SPRING GARDENS |
CARMARTHENSHIRE, WHALES,
GB
SA34 OHR
|
|
Applicant Contact |
ANTHONY THOMAS |
Correspondent |
THE MAGSTIM COMPANY LTD. |
SPRING GARDENS |
CARMARTHENSHIRE, WHALES,
GB
SA34 OHR
|
|
Correspondent Contact |
ANTHONY THOMAS |
Regulation Number | 882.1870
|
Classification Product Code |
|
Date Received | 07/08/2005 |
Decision Date | 12/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|