K232953
- 510(k) number
- K232953
- Device name
- AquaBplus; AquaB LITE
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- FIP — Subsystem, Water Purification
- Decision date
- 2024-06-13
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232953.pdf
Official FDA record: K232953
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.