SMDIE DEVICE INTERFACING SYSTEM

SMDIE DEVICE INTERFACING SYSTEM is an FDA 510(k)-cleared medical device (K061590) manufactured by Siemens Medical Solutions Health Services Corporat. 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 20, 2006. Regulation: 8.