GYRUS ACMI PK BUTTON ELECTRODE

GYRUS ACMI PK BUTTON ELECTRODE is an FDA 510(k)-cleared medical device (K093181) manufactured by Gyrus Acmi, 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 February 23, 2010. Regulation: 8.