Clearance Summary
Brain Anesthesia Response Monitor (Bar Monitor) received FDA 510(k) clearance under submission number K213273, sponsored by Cortical Dynamics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-09-01.
- Submission: K213273
- Applicant / Sponsor: Cortical Dynamics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2023-09-01
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.