Clearance Summary
Brainsway Deep TMS System received FDA 510(k) clearance under submission number K183303, sponsored by Brainsway , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-03-08.
- Submission: K183303
- Applicant / Sponsor: Brainsway , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5802
- Decision date: 2019-03-08
Classification & Regulation
This clearance is catalogued under FDA product code QCI and 21 CFR 882.5802, within the Neurology review panel as a Class II device.