Clearance Summary
FEEDBACK EDR SYSTEM MODEL EDR-100 received FDA 510(k) clearance under submission number K770790, 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 1977-05-10.
- Submission: K770790
- Applicant / Sponsor: Bio-Feedback Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1977-05-10
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.