Clearance Summary
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM received FDA 510(k) clearance under submission number K013677, sponsored by Usfilter/Ionpure, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2002-03-08.
- Submission: K013677
- Applicant / Sponsor: Usfilter/Ionpure, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2002-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FIP and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.