Clearance Summary
2300 SERIES MGO PORTABLE OXYGEN received FDA 510(k) clearance under submission number K134023, sponsored by Ultra Electronics Limited Precision Air & Land SY. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2014-04-25.
- Submission: K134023
- Applicant / Sponsor: Ultra Electronics Limited Precision Air & Land SY
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2014-04-25
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.