Clearance Summary
OSRAM ITOS received FDA 510(k) clearance under submission number K110326, sponsored by Osram Sylvania, 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 2011-10-27.
- Submission: K110326
- Applicant / Sponsor: Osram Sylvania, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4770
- Decision date: 2011-10-27
Classification & Regulation
This clearance is catalogued under FDA product code ERA and 21 CFR 874.4770, within the Ear, Nose, Throat review panel as a Class I device.