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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 Smoking Cessation
510(k) Number K200957
Device Name Brainsway Deep TMS System
Applicant
Brainsway Ltd.
19 Hartom St. (Bynet Bldg) Har Hotzvim
Jerusalem,  IL 9777518
Applicant Contact Ahava Stein
Correspondent
A. Stein-Regulatory Affairs Consulting Ltd.
20 Hata'as Str., Suite 102
Kfar Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number882.5802
Classification Product Code
QMD  
Date Received04/09/2020
Decision Date 08/21/2020
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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