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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 K232235
Device Name Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
Applicant
The Magstim Company , Ltd.
Spring Gardens
Whitland,  GB SA340HR
Applicant Contact Daniel Gregory
Correspondent
The Magstim Company , Ltd.
Spring Gardens
Whitland,  GB SA340HR
Correspondent Contact Daniel Gregory
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Code
QCI  
Date Received07/27/2023
Decision Date 10/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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