510(k) DEN170078
DEN170078 is an FDA 510(k) premarket notification submitted by Brainways , Ltd. for the device "Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System". The FDA issued a decision of De Novo Granted on August 17, 2018. The device falls under product code QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder), a Class II device regulated under 21 CFR 882.5802.
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).