Clearance Summary
SLEEP APP received FDA 510(k) clearance under submission number K100185, sponsored by Sleep Medicine Network, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-11-19.
- Submission: K100185
- Applicant / Sponsor: Sleep Medicine Network, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2010-11-19
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.