
Outset Medical, Inc.
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Tablo® Hemodialysis System is an FDA 510(k)-cleared medical device (K233335) manufactured by Outset Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2023. Regulation: 8.