Clearance Summary
BRM2 BRAIN MONITOR received FDA 510(k) clearance under submission number K033010, sponsored by Brainz Instruments , 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 2003-10-10.
- Submission: K033010
- Applicant / Sponsor: Brainz Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2003-10-10
Classification & Regulation
This clearance is catalogued under FDA product code OLT and 21 CFR 882.1400, within the Neurology review panel as a Class II device.