
Mediguide, Ltd.
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GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) is an FDA 510(k)-cleared medical device (K102905) 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 28, 2010. Regulation: 8.