Clearance Summary
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 received FDA 510(k) clearance under submission number K982243, sponsored by Canogen International , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1998-11-19.
- Submission: K982243
- Applicant / Sponsor: Canogen International , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1998-11-19
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.