Clearance Summary
ROUND WINDOW CATH received FDA 510(k) clearance under submission number K965115, sponsored by Neuro-Biometrix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1997-03-10.
- Submission: K965115
- Applicant / Sponsor: Neuro-Biometrix, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3880
- Decision date: 1997-03-10
Classification & Regulation
This clearance is catalogued under FDA product code ETD and 21 CFR 874.3880, within the Ear, Nose, Throat review panel as a Class II device.