Clearance Summary
BIS ENGINE received FDA 510(k) clearance under submission number K002837, sponsored by Aspect Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2000-09-19.
- Submission: K002837
- Applicant / Sponsor: Aspect Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2000-09-19
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.