Clearance Summary
EEG BIOFEEDBACK DEVICE ACCESSORY received FDA 510(k) clearance under submission number K842021, sponsored by Electronics Research & Production. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-07-20.
- Submission: K842021
- Applicant / Sponsor: Electronics Research & Production
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1984-07-20
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.