K233335
- 510(k) number
- K233335
- Device name
- Tablo® Hemodialysis System
- Applicant
- Outset Medical, Inc. CA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2023-12-05
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233335.pdf
Official FDA record: K233335
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.