Clearance Summary
ISEN-Goggles received FDA 510(k) clearance under submission number K152727, sponsored by Isen 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 2016-04-26.
- Submission: K152727
- Applicant / Sponsor: Isen Tech & Trading Company, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1460
- Decision date: 2016-04-26
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.