Clearance Summary
OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 received FDA 510(k) clearance under submission number K033863, sponsored by Ox-Gen, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-08-22.
- Submission: K033863
- Applicant / Sponsor: Ox-Gen, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2005-08-22
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.