Clearance Summary
DreamClear received FDA 510(k) clearance under submission number K240646, sponsored by Somnomed Technologies Inc., Doing Business AS Remware. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-09-04.
- Submission: K240646
- Applicant / Sponsor: Somnomed Technologies Inc., Doing Business AS Remware
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 2024-09-04
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.