Clearance Summary
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 received FDA 510(k) clearance under submission number K991569, sponsored by 02 Marketing Group, 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 1999-08-03.
- Submission: K991569
- Applicant / Sponsor: 02 Marketing Group, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1999-08-03
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.