APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) is an FDA 510(k)-cleared medical device (K001250) 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 August 15, 2000. Regulation: 8.