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Mediguide, Ltd.
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GUIDED MEDICAL POSITIONING SYSTEM (GMPS) is an FDA 510(k)-cleared medical device (K091781) manufactured by Mediguide, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 2009. Regulation: 8.