Clearance Summary
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A received FDA 510(k) clearance under submission number K213825, sponsored by Jiangsu Yuyue Medical Equipment & Supply 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 2023-04-28.
- Submission: K213825
- Applicant / Sponsor: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2023-04-28
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.