MODIFICATION TO SOLAR 9500 INFORMATION MONITOR

MODIFICATION TO SOLAR 9500 INFORMATION MONITOR is an FDA 510(k)-cleared medical device (K030575) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2003. Regulation: 8.