K240920
- 510(k) number
- K240920
- Device name
- HemoCare Bicarbonate Concentrate Set (BCS)
- Applicant
- Deka Research and Development NH · US
- Product code
- KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Po
- Decision date
- 2024-07-12
- Date received
- 2024-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240920.pdf
Official FDA record: K240920
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.