Clearance Summary
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance under submission number K041884, sponsored by Mueller Water Conditioning, 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 2005-02-28.
- Submission: K041884
- Applicant / Sponsor: Mueller Water Conditioning, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2005-02-28
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.