Clearance Summary
MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY received FDA 510(k) clearance under submission number K830046, sponsored by Greene & Kellogg, 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 1983-02-07.
- Submission: K830046
- Applicant / Sponsor: Greene & Kellogg, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1983-02-07
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.