NEO-STAT DIALYSATE METER

NEO-STAT DIALYSATE METER is an FDA 510(k)-cleared medical device (K920810) manufactured by Automata Medical Instrumentation, Inc.. 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 January 14, 1993. Regulation: 8.