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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K051864
Device Name MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
Applicant
The Magstim Company , Ltd.
Spring Gardens
Whitland, Dyfed Wales,  GB SA34 OHR
Applicant Contact ANTHONY THOMAS
Correspondent
The Magstim Company , Ltd.
Spring Gardens
Whitland, Dyfed Wales,  GB SA34 OHR
Correspondent Contact ANTHONY THOMAS
Regulation Number882.1870
Classification Product Code
GWF  
Date Received07/08/2005
Decision Date 12/21/2005
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
Recalls CDRH Recalls
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