Clearance Summary
OXYGEN MEDICELS, CITICELS received FDA 510(k) clearance under submission number K041773, sponsored by City Technology Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2004-07-15.
- Submission: K041773
- Applicant / Sponsor: City Technology Limited
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 2004-07-15
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.