NEO-2 METER

NEO-2 METER is an FDA 510(k)-cleared medical device (K992431) manufactured by Automata 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 October 12, 1999. Regulation: 8.