K230193
- 510(k) number
- K230193
- Device name
- Servator P Plus SALF Solution
- Applicant
- S.A.L.F. Spa IT
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2023-09-21
- Date received
- 2023-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K230193.pdf
Official FDA record: K230193
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.