PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 is an FDA 510(k)-cleared medical device (K980658) 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 May 18, 1998. Regulation: 8.