510(k) K233335

Tablo® Hemodialysis System by Outset Medical, Inc. — Product Code KDI

K233335 is an FDA 510(k) premarket notification submitted by Outset Medical, Inc. for the device "Tablo® Hemodialysis System". The FDA issued a decision of Substantially Equivalent on December 5, 2023. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Outset Medical, Inc. has at least 9 other 510(k) clearances on record.