ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X is an FDA 510(k)-cleared medical device (K991512) manufactured by Asahi Medical Co., Ltd.. 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 July 28, 1999. Regulation: 8.