WAK WEARABLE ARTIFICIAL KIDNEY

WAK WEARABLE ARTIFICIAL KIDNEY is an FDA 510(k)-cleared medical device (K830291) manufactured by Wak-Utah. 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 March 28, 1983. Regulation: 8.