MRI COMPATIBLE MONITOR AND ACCESSORIES

MRI COMPATIBLE MONITOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K980362) manufactured by Datex-Engstrom, 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 June 29, 1998. Regulation: 8.