SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847

SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 is an FDA 510(k)-cleared medical device (K062278) manufactured by Spacelabs Medical, 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 September 18, 2006. Regulation: 8.