Clearance Summary
BLEASE700/900 SERIES VENTILATORS received FDA 510(k) clearance under submission number K112729, sponsored by Spacelabs Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2012-06-11.
- Submission: K112729
- Applicant / Sponsor: Spacelabs Healthcare
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2012-06-11
Classification & Regulation
This clearance is catalogued under FDA product code CBK and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.