Device Classification Name |
transcranial magnetic stimulator
|
510(k) Number |
K143531 |
Device Name |
Rapid Therapy System |
Applicant |
MAGSTIM COMPANY LIMITED |
SPRING GARDENS, WHITLAND |
CARMARTHENSHIRE,
GB
SA34 OHR
|
|
Applicant Contact |
Charles Hounsell |
Correspondent |
HOGAN LOVELLS US LLP |
1835 MARKET ST 29TH FL |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
Steven B Datlof |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 12/12/2014 |
Decision Date | 05/08/2015 |
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
|
|
|