510(k) K150880

Tablo Console with Wireless Capability by Outset Medical — Product Code KDI

K150880 is an FDA 510(k) premarket notification submitted by Outset Medical for the device "Tablo Console with Wireless Capability". The FDA issued a decision of Substantially Equivalent on May 1, 2015. 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 has at least 9 other 510(k) clearances on record.