Clearance Summary
Express 4 Sleep appliance/CPAP Sidekick appliance received FDA 510(k) clearance under submission number K173856, sponsored by Moses Appliances, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-06-26.
- Submission: K173856
- Applicant / Sponsor: Moses Appliances, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2018-06-26
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.