Clearance Summary
B4C System received FDA 510(k) clearance under submission number K201989, sponsored by Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-10-08.
- Submission: K201989
- Applicant / Sponsor: Braincare Desenvolvimento E Inovacao Tecnologica S.A.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2021-10-08
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.