Clearance Summary
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES received FDA 510(k) clearance under submission number K001727, sponsored by Blease Medical Equipment , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2000-08-09.
- Submission: K001727
- Applicant / Sponsor: Blease Medical Equipment , Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2000-08-09
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.