PSN HEMODIALYZER, MODELS PSN 170, PSN 210

PSN HEMODIALYZER, MODELS PSN 170, PSN 210 is an FDA 510(k)-cleared medical device (K001422) manufactured by Baxter Healthcare Corp. 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 June 1, 2000. Regulation: 8.