Clearance Summary
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN received FDA 510(k) clearance under submission number K081508, sponsored by Shenyang Canta Medical Tech. 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 2008-08-27.
- Submission: K081508
- Applicant / Sponsor: Shenyang Canta Medical Tech. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2008-08-27
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.