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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 K203735
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 St. , Suite 102
K Far Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number882.5805
Classification Product Code
OBP  
Date Received12/21/2020
Decision Date 04/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04679753
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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