K233950
- 510(k) number
- K233950
- Device name
- pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Po
- Decision date
- 2024-05-10
- Date received
- 2023-12-14
- 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: K233950.pdf
Official FDA record: K233950
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.