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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 K122288
FOIA Releasable 510(k) K122288
Device Name BRAINSWAY DEEP TMS SYSTEM
Applicant
Brainsway , Ltd.
20 Hata'As St.(Pob 124)
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Brainsway , Ltd.
20 Hata'As St.(Pob 124)
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number882.5805
Classification Product Code
OBP  
Date Received07/30/2012
Decision Date 01/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT00927173
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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