Clearance Summary
SNOREX received FDA 510(k) clearance under submission number K971818, sponsored by Snorex (Nz) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-12-18.
- Submission: K971818
- Applicant / Sponsor: Snorex (Nz) , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1997-12-18
Classification & Regulation
This clearance is catalogued under FDA product code LQZ and 21 CFR 872.5570, within the Dental review panel as a Class II device.