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Datex-Ohmeda Inc., A Division of Instrumentarium C
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ENGSTROM CARESTATION, ENGSTROM PRO is an FDA 510(k)-cleared medical device (K093886) manufactured by Datex-Ohmeda Inc., A Division of Instrumentarium C. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 2010. Regulation: 8.