Clearance Summary
TANSCU O2 received FDA 510(k) clearance under submission number K090681, sponsored by Electrochemical Oxygen Concepts, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-08-12.
- Submission: K090681
- Applicant / Sponsor: Electrochemical Oxygen Concepts, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5650
- Decision date: 2009-08-12
Classification & Regulation
This clearance is catalogued under FDA product code KPJ and 21 CFR 878.5650, within the General, Plastic Surgery review panel as a Class II device.