MODIFICATION TO ARKIVE(TM)

MODIFICATION TO ARKIVE(TM) is an FDA 510(k)-cleared medical device (K872178) manufactured by Diatek, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 1988. Regulation: 8.