MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414

MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 is an FDA 510(k)-cleared medical device (K014294) 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 January 24, 2002. Regulation: 8.