Clearance Summary
BRM3 BRAIN MONITOR received FDA 510(k) clearance under submission number K071449, 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 2007-09-14.
- Submission: K071449
- Applicant / Sponsor: Brainz Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2007-09-14
Classification & Regulation
This clearance is catalogued under FDA product code OMA and 21 CFR 882.1400, within the Neurology review panel as a Class II device.