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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 Stimulation System For Obsessive-Compulsive Disorder
510(k) Number K183303
Device Name Brainsway Deep TMS System
Applicant
Brainsway Ltd.
19 Hartom St. (Bynet Bldg) Har Hotzvim
Jerusalem,  IL 9777518
Applicant Contact Moria Ankri
Correspondent
Hogan Lovells US LLP
1735 Market St., 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.5802
Classification Product Code
QCI  
Date Received11/27/2018
Decision Date 03/08/2019
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
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