
Ge Medical Systems Information Technologies
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MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K073462) 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 January 10, 2008. Regulation: 8.