Clearance Summary
BNA ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K121119, sponsored by Eiminda , 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 2014-07-25.
- Submission: K121119
- Applicant / Sponsor: Eiminda , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2014-07-25
Classification & Regulation
This clearance is catalogued under FDA product code OLU and 21 CFR 882.1400, within the Neurology review panel as a Class II device.