Clearance Summary
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System received FDA 510(k) clearance under submission number K191027, sponsored by Maquet Critical Care AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2020-03-18.
- Submission: K191027
- Applicant / Sponsor: Maquet Critical Care AB
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2020-03-18
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.