K252181
- 510(k) number
- K252181
- Device name
- AquaA
- Applicant
- Fresenius Medical Care North America MA · US
- Product code
- FIP — Subsystem, Water Purification
- Decision date
- 2025-09-09
- Date received
- 2025-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252181.pdf
Official FDA record: K252181
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.