SOLAR 9500 INFORMATION MONITOR

SOLAR 9500 INFORMATION MONITOR is an FDA 510(k)-cleared medical device (K990068) manufactured by General Electric Medical Systems Information Techn. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 1999. Regulation: 8.