ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR

ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR is an FDA 510(k)-cleared medical device (K992411) manufactured by Medical Data Electronics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 1999. Regulation: 8.