Clearance Summary
ANTI-SNORING/SLEEP APNEA DEVICE received FDA 510(k) clearance under submission number K042161, sponsored by Rj & VK Bird Pty , 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 2004-10-27.
- Submission: K042161
- Applicant / Sponsor: Rj & VK Bird Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2004-10-27
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.