Clearance Summary
COMPRESSED AIR & OXYGEN GEN./DELIVERY SY received FDA 510(k) clearance under submission number K803232, sponsored by Dri-Aire, 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 1981-02-02.
- Submission: K803232
- Applicant / Sponsor: Dri-Aire, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1981-02-02
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.