Clearance Summary
OTO-CEM received FDA 510(k) clearance under submission number K011338, sponsored by Ototech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-09-13.
- Submission: K011338
- Applicant / Sponsor: Ototech, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2001-09-13
Classification & Regulation
This clearance is catalogued under FDA product code NEA and 21 CFR 872.3275, within the Dental review panel as a Class II device.