Device Classification Name |
transcranial magnetic stimulator
|
510(k) Number |
K222171 |
Device Name |
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ |
Applicant |
Magstim Company Ltd |
Spring Gardens |
Whitland,
GB
SA340HR
|
|
Applicant Contact |
Tom Campbell |
Correspondent |
Magstim Company Ltd |
Spring Gardens |
Whitland,
GB
SA340HR
|
|
Correspondent Contact |
Tom Campbell |
Regulation Number | 882.5805
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2022 |
Decision Date | 01/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|