K232776
- 510(k) number
- K232776
- Device name
- Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
- Applicant
- Outset Medical, Inc. CA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-05-03
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K232776.pdf
Official FDA record: K232776
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.