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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
Device Name BRAINSWAY DEEP TMS SYSTEM
Original Applicant
BRAINSWAY, LTD
20 hata'as st. (pob 124)
kfar saba,  IS 44425
Original Contact ahava stein
Regulation Number882.5805
Classification Product Code
OBP  
Date Received07/30/2012
Decision Date 01/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Clinical Trials NCT00927173
Reviewed by Third Party No
Expedited Review No
Combination Product No
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