Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Number882.5805
Classification Product Code
OBP  
Subsequent Product Code
QCI  
Date Received07/21/2022
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
Predetermined Change
Control Plan Authorized		 No
-
-