Clearance Summary
ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV received FDA 510(k) clearance under submission number K860914, 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 1986-06-06.
- Submission: K860914
- Applicant / Sponsor: Bio-Feedback Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1845
- Decision date: 1986-06-06
Classification & Regulation
This clearance is catalogued under FDA product code GWK and 21 CFR 882.1845, within the Neurology review panel as a Class II device.