Clearance Summary
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS received FDA 510(k) clearance under submission number K112107, sponsored by Neurovirtual USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-10-28.
- Submission: K112107
- Applicant / Sponsor: Neurovirtual USA, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2011-10-28
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.