DATASCOPE PASSPORT MONITOR WITH CO2

DATASCOPE PASSPORT MONITOR WITH CO2 is an FDA 510(k)-cleared medical device (K921526) manufactured by Datascope Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 1992. Regulation: 8.