Clearance Summary
COMPANION 492 OXYGEN CONCENTRATOR received FDA 510(k) clearance under submission number K843243, sponsored by Puritan Bennett Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1984-08-22.
- Submission: K843243
- Applicant / Sponsor: Puritan Bennett Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1984-08-22
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.