Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder

Brainways Ltd.

The following data is part of a De Novo classification by Brainways Ltd. with the FDA for Brainsway Deep Transcranial Magnetic Stimulation (dtms) System.

Pre-market Notification Details

DeNovo IDDEN170078
Device Name:Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
ClassificationTranscranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Applicant Brainways Ltd. bynet Bldg. P.o.b. 45169 19 Hartum Str. Har Hotzvim,  IL 9777518
ContactAhava Stein
Product CodeQCI  
CFR Regulation Number882.5802 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypeDirect
Date Received2017-09-29
Decision Date2018-08-17
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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