Clearance Summary
DEVO/MC29 OXYGEN CONCENTRATOR MC29D received FDA 510(k) clearance under submission number K852209, sponsored by The Devilbiss Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1985-06-24.
- Submission: K852209
- Applicant / Sponsor: The Devilbiss Co.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1985-06-24
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.