Clearance Summary
O2Vent W received FDA 510(k) clearance under submission number K171316, sponsored by Oventus Manufacturing Pty, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-07-11.
- Submission: K171316
- Applicant / Sponsor: Oventus Manufacturing Pty, Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2017-07-11
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.