Clearance Summary
INVENT SNORING DEVICE received FDA 510(k) clearance under submission number K120665, sponsored by Ventus Medical, 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 2012-06-12.
- Submission: K120665
- Applicant / Sponsor: Ventus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3900
- Decision date: 2012-06-12
Classification & Regulation
This clearance is catalogued under FDA product code LWF and 21 CFR 874.3900, within the Ear, Nose, Throat review panel as a Class I device.