Clearance Summary
Oxygen Concentrator received FDA 510(k) clearance under submission number K230969, sponsored by Jiangsu Jumao X-Care 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 2023-11-09.
- Submission: K230969
- Applicant / Sponsor: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2023-11-09
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.