Clearance Summary
MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES received FDA 510(k) clearance under submission number K100920, sponsored by Sequal Technologies Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2010-11-29.
- Submission: K100920
- Applicant / Sponsor: Sequal Technologies Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2010-11-29
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.