Clearance Summary
ICS CHARTR EP 200 WITH VEMP received FDA 510(k) clearance under submission number K143670, sponsored by Gn Otometrics A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-10-23.
- Submission: K143670
- Applicant / Sponsor: Gn Otometrics A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 2015-10-23
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.