Clearance Summary
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance under submission number K980182, sponsored by Usfilter/Ionpure, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1998-11-16.
- Submission: K980182
- Applicant / Sponsor: Usfilter/Ionpure, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 1998-11-16
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.