SIRECUST 420 PATIENT DIALOG MONITOR

SIRECUST 420 PATIENT DIALOG MONITOR is an FDA 510(k)-cleared medical device (K851400) manufactured by Siemens Medical Solutions USA, 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 25, 1985. Regulation: 8.