Clearance Summary
BIS SRS (SEMI-RESUABLE SENSOR) received FDA 510(k) clearance under submission number K050313, sponsored by Aspect Medical 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 2005-02-24.
- Submission: K050313
- Applicant / Sponsor: Aspect Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1750
- Decision date: 2005-02-24
Classification & Regulation
This clearance is catalogued under FDA product code GWY and 21 CFR 882.1750, within the Neurology review panel as a Class I device.