BrainsWay Deep TMS System

Transcranial Magnetic Stimulator

BrainsWay Ltd.

The following data is part of a premarket notification filed by Brainsway Ltd. with the FDA for Brainsway Deep Tms System.

Pre-market Notification Details

Device IDK220819
510k NumberK220819
Device Name:BrainsWay Deep TMS System
ClassificationTranscranial Magnetic Stimulator
Applicant BrainsWay Ltd. 19 Hartom St. (Bynet Bldg) Har Hotzvim Jerusalem,  IL 9777518
ContactAhava Stein
CorrespondentAhava Stein
A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 21 Kfar Saba,  IL 4442518
Product CodeOBP  
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-21
Decision Date2022-08-26

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