
Environmental Tectonics Corp.
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O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) is an FDA 510(k)-cleared medical device (K092991) manufactured by Environmental Tectonics Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 2010. Regulation: 8.