Clearance Summary
XENON XE 127/XE 133 GAS DISPENSER received FDA 510(k) clearance under submission number K843640, sponsored by Mallinckrodt Critical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-01-14.
- Submission: K843640
- Applicant / Sponsor: Mallinckrodt Critical Care
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1390
- Decision date: 1985-01-14
Classification & Regulation
This clearance is catalogued under FDA product code IYT and 21 CFR 892.1390, within the Radiology review panel as a Class II device.