TRANSONIC FLOW-QC SET MODEL ADT1010

TRANSONIC FLOW-QC SET MODEL ADT1010 is an FDA 510(k)-cleared medical device (K021571) manufactured by Transonic Systems, 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 August 11, 2002. Regulation: 8.