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510(k) DEN170078

Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System by Brainways , Ltd. — Product Code QCI

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 17, 2018
Date Received
September 29, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device Class
Class II
Regulation Number
882.5802
Review Panel
NE
Submission Type

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

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