
Ge Medical Systems Information Technologies, Inc.
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MAC 5500 HD, MAC 3500 is an FDA 510(k)-cleared medical device (K110266) manufactured by Ge Medical Systems Information Technologies, 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 April 28, 2011. Regulation: 8.