Clearance Summary
PREMIER O2 OXYGEN CONCENTRATOR received FDA 510(k) clearance under submission number K844223, sponsored by Everest & Jennings, 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 1984-12-24.
- Submission: K844223
- Applicant / Sponsor: Everest & Jennings, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1984-12-24
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.