K232171
- 510(k) number
- K232171
- Device name
- Purema® H Hemoconcentrator (EtO Sterilized)
- Applicant
- Tecnoideal America MD · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-02-07
- Date received
- 2023-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232171.pdf
Official FDA record: K232171
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.