Clearance Summary
BIS/EEG MODULE received FDA 510(k) clearance under submission number K012466, sponsored by General Electric Medical Systems Information Techn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-10-01.
- Submission: K012466
- Applicant / Sponsor: General Electric Medical Systems Information Techn
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2001-10-01
Classification & Regulation
This clearance is catalogued under FDA product code OLW and 21 CFR 882.1400, within the Neurology review panel as a Class II device.