K233213
- 510(k) number
- K233213
- Device name
- NxStage PureFlow Solution
- Applicant
- Nxstage Medical, Inc. MA · US
- Product code
- KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Po
- Decision date
- 2024-01-18
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K233213.pdf
Official FDA record: K233213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.