About This 510(k) Submission
K232776 is an FDA 510(k) clearance for the Tablo? Hemodialysis System; TabloCart? with Prefiltration Drawer, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Outset Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on May 3, 2024, 235 days after receiving the submission on September 11, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.