Device Classification Name |
Transcranial Magnetic Stimulator
|
510(k) Number |
K171051 |
Device Name |
HORIZON Therapy System |
Applicant |
Magstim Company Ltd. |
Spring Gardens |
Whitland,
GB
SA34 0HR
|
|
Applicant Contact |
Tom Campbell |
Correspondent |
Magstim Company Ltd. |
Spring Gardens |
Whitland,
GB
SA34 0HR
|
|
Correspondent Contact |
Tom Campbell |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 04/10/2017 |
Decision Date | 09/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|