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Innovision Medical Technologies, LLC
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IISIS, VERSION 1.0 is an FDA 510(k)-cleared medical device (K052244) manufactured by Innovision Medical Technologies, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 2005. Regulation: 8.