Clearance Summary
NEBA SYSTEM received FDA 510(k) clearance under submission number DEN110019, sponsored by Lexicor Medical Technology, LLC. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-07-15.
- Submission: DEN110019
- Applicant / Sponsor: Lexicor Medical Technology, LLC
- Clearance pathway: Post-NSE
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1440
- Decision date: 2013-07-15
Classification & Regulation
This clearance is catalogued under FDA product code NCG and 21 CFR 882.1440, within the Neurology review panel as a Class II device.