Clearance Summary
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 received FDA 510(k) clearance under submission number K051629, sponsored by Blease USA, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-09-23.
- Submission: K051629
- Applicant / Sponsor: Blease USA, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2005-09-23
Classification & Regulation
This clearance is catalogued under FDA product code BSZ and 21 CFR 868.5160, within the Anesthesiology review panel as a Class II device.