K250471
- 510(k) number
- K250471
- Device name
- AquaC UNO H
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- FIP — Subsystem, Water Purification
- Decision date
- 2025-11-14
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K250471.pdf
Official FDA record: K250471
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.