Clearance Summary
BIO-DETEK TRACERITE EEG ELECTRODE received FDA 510(k) clearance under submission number K920264, sponsored by Bio-Detek, 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 1992-06-02.
- Submission: K920264
- Applicant / Sponsor: Bio-Detek, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1992-06-02
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.