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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 SA34 0HR
Applicant Contact Tom Campbell
Correspondent
Magstim Company Ltd.
Spring Gardens
Whitland,  GB SA34 0HR
Correspondent Contact Tom Campbell
Regulation Number882.5805
Classification Product Code
OBP  
Date Received05/05/2021
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
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