Clearance Summary
AXS-590 SERIES received FDA 510(k) clearance under submission number K091650, sponsored by Swr International, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2009-11-24.
- Submission: K091650
- Applicant / Sponsor: Swr International, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2009-11-24
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.