Clearance Summary
SOMNOSCREEN received FDA 510(k) clearance under submission number K060708, sponsored by Somnomedics GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2007-01-24.
- Submission: K060708
- Applicant / Sponsor: Somnomedics GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2007-01-24
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.