K251851
- 510(k) number
- K251851
- Device name
- DIASAFEplusUS (F00013010)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- FIP — Subsystem, Water Purification
- Decision date
- 2025-10-09
- Date received
- 2025-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251851.pdf
Official FDA record: K251851
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.