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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 K173540
Device Name Brainsway Deep (DTMS) System
Applicant
Brainsway , Ltd.
19 Hartom St.
Jerusalem,  IL 9777518
Applicant Contact Ahava Stein
Correspondent
A. Stein Regulatory Affairs Consulting , Ltd.
20 Hata As St. , Suite 102
Kfar Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number882.5805
Classification Product Code
OBP  
Date Received11/15/2017
Decision Date 05/03/2018
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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