Clearance Summary
X4 SYSTEM received FDA 510(k) clearance under submission number K130013, sponsored by Advanced Brain Monitoring, 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 2013-01-31.
- Submission: K130013
- Applicant / Sponsor: Advanced Brain Monitoring, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2013-01-31
Classification & Regulation
This clearance is catalogued under FDA product code OMC and 21 CFR 882.1400, within the Neurology review panel as a Class II device.