DATEX-ENGSTROM NETWORK

DATEX-ENGSTROM NETWORK is an FDA 510(k)-cleared medical device (K974101) 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 February 5, 1998. Regulation: 8.