| Device Classification Name |
Stimulator, Electrical, Evoked Response
|
| 510(k) Number |
K992911 |
| Device Name |
MAGSTIM RAPID |
| Applicant |
| Magstim Corporation US |
| 730 Fifth Ave. |
| 9th Floor |
|
New York,
NY
10019
|
|
| Applicant Contact |
REZA JALINOUS |
| Correspondent |
| Magstim Corporation US |
| 730 Fifth Ave. |
| 9th Floor |
|
New York,
NY
10019
|
|
| Correspondent Contact |
REZA JALINOUS |
| Regulation Number | 882.1870 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 08/30/1999 |
| Decision Date | 01/07/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|