COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION

COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION is an FDA 510(k)-cleared medical device (K944720) manufactured by Nuccardiac Software, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 1994. Regulation: 8.