Clearance Summary
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) received FDA 510(k) clearance under submission number K900063, sponsored by Bio-Feedback Systems, 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 1990-02-16.
- Submission: K900063
- Applicant / Sponsor: Bio-Feedback Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 1990-02-16
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.