K233159
- 510(k) number
- K233159
- Device name
- pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Po
- Decision date
- 2023-12-01
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233159.pdf
Official FDA record: K233159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.