Clearance Summary
LONGFEI LFY-I-5 OXYGEN CONCENTRATOR received FDA 510(k) clearance under submission number K033405, sponsored by Zhejiang Longfei Industrial 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 2005-10-18.
- Submission: K033405
- Applicant / Sponsor: Zhejiang Longfei Industrial Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2005-10-18
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.