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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 K162935
Device Name Rapid2 Therapy System
Applicant
MAGSTIM COMPANY LTD.
SPRING GARDENS
Whitland,  GB SA34 0HR
Applicant Contact Kevyn Beard
Correspondent
MAGSTIM COMPANY LTD.
SPRING GARDENS
Whitland,  GB SA34 0HR
Correspondent Contact Kevyn Beard
Regulation Number882.5805
Classification Product Code
OBP  
Date Received10/20/2016
Decision Date 03/10/2017
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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