Clearance Summary
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 received FDA 510(k) clearance under submission number K062716, sponsored by Eco-Rx, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-10-27.
- Submission: K062716
- Applicant / Sponsor: Eco-Rx, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6500
- Decision date: 2006-10-27
Classification & Regulation
This clearance is catalogued under FDA product code FRA and 21 CFR 880.6500, within the General Hospital review panel as a Class II device.