
Baxter Healthcare Corportation
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AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is an FDA 510(k)-cleared medical device (K201809) manufactured by Baxter Healthcare Corportation. 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 9, 2021. Regulation: 8.