Clearance Summary
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM received FDA 510(k) clearance under submission number K001811, sponsored by Neu-Ion, 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 2000-10-25.
- Submission: K001811
- Applicant / Sponsor: Neu-Ion, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2000-10-25
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.