Clearance Summary
AURA ICP MONITORING SYSTEM received FDA 510(k) clearance under submission number K172209, sponsored by Branchpoint Technologies, 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 2018-05-18.
- Submission: K172209
- Applicant / Sponsor: Branchpoint Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2018-05-18
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.