K243920
- 510(k) number
- K243920
- Device name
- Purema H Hemoconcentrator - Pediatric
- Applicant
- Medica USA, Inc. MN · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-09-19
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243920.pdf
Official FDA record: K243920
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.