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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 K210201
Device Name Deep Transcranial Magnetic Stimulation (DTMS) System
Brainsway Ltd.
19 Hartom St. (Bynet Bldg) Har Hotzvim
Jerusalem,  IL 9777518
Applicant Contact Ahava Stein
A. Stein-Regulatort Affairs Consulting Ltd.
18 Hata'as Str., Suite 21
Kfar Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number882.5805
Classification Product Code
Date Received01/25/2021
Decision Date 08/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No