PASSPORT 5L-CE MODEL 0998-00-0131XXX

PASSPORT 5L-CE MODEL 0998-00-0131XXX is an FDA 510(k)-cleared medical device (K974178) manufactured by Datascope Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1998. Regulation: 8.