KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II is an FDA 510(k)-cleared medical device (K983626) manufactured by Alaris Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 1999. Regulation: 8.