Clearance Summary
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. received FDA 510(k) clearance under submission number K060657, sponsored by Breas Medical AB. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2006-08-18.
- Submission: K060657
- Applicant / Sponsor: Breas Medical AB
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2006-08-18
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.