Clearance Summary
ISEN-Goggles with Data Viewer received FDA 510(k) clearance under submission number K163270, sponsored by Isent Tech & Trading Company, 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 2017-09-25.
- Submission: K163270
- Applicant / Sponsor: Isent Tech & Trading Company, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1460
- Decision date: 2017-09-25
Classification & Regulation
This clearance is catalogued under FDA product code GWN and 21 CFR 882.1460, within the Neurology review panel as a Class II device.