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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 K222196
Device Name 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.
18 Hata`As St. , Suite 21
Kfar Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number882.5805
Classification Product Code
OBP  
Date Received07/22/2022
Decision Date 05/31/2024
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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