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Device Classification Name
Transcranial Magnetic Stimulator
510(k) Number
K211389 Device Name
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
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
Date Received 05/05/2021 Decision Date 09/14/2021 Decision
Substantially Equivalent
(SESE) Regulation Medical Specialty
Neurology
510k Review Panel
Neurology
Summary
Summary
Type
Traditional
Reviewed by Third Party
No
Combination Product
No
Predetermined Change
Control Plan Authorized
No
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