PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 is an FDA 510(k)-cleared medical device (K001685) 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 November 14, 2000. Regulation: 8.