K242155
- 510(k) number
- K242155
- Device name
- DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
- Applicant
- NIKKISO CO., LTD. JP
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-05-15
- Date received
- 2024-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242155.pdf
Official FDA record: K242155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.