Cleared Traditional

Tablo Hemodialysis System

K200741 · Outset Medical, Inc. · Gastroenterology & Urology
Mar 2020
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K200741 is an FDA 510(k) clearance for the Tablo Hemodialysis System, 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 March 31, 2020, 8 days after receiving the submission on March 23, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number K200741 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2020
Decision Date March 31, 2020
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5860

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