Moda-flx Hemodialysis System and Cartridge

Moda-flx Hemodialysis System and Cartridge is an FDA 510(k)-cleared medical device (K233798) manufactured by Diality, 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 August 1, 2024. Regulation: 8.