Clearance Summary
A&J 5L POCA SERIES OXYGEN CONCENTRATOR received FDA 510(k) clearance under submission number K121531, sponsored by Zhongshan A&J Medical Equipment Co., 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 2012-07-17.
- Submission: K121531
- Applicant / Sponsor: Zhongshan A&J Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2012-07-17
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.