PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX

PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX is an FDA 510(k)-cleared medical device (K993531) 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 January 12, 2000. Regulation: 8.