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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name transcranial magnetic stimulation system for obsessive-compulsive disorder
De Novo Number DEN170078
Device Name Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
Requester
brainways , ltd.
bynet bldg. p.o.b. 45169
19 hartum st.
har hotzvim,  IL 9777518
Contact ahava stein
Regulation Number882.5802
Classification Product Code
QCI  
Date Received09/29/2017
Decision Date 08/17/2018
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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