
Datex-Ohmeda, Inc.
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Aisys CS2 is an FDA 510(k)-cleared medical device (K170872) manufactured by Datex-Ohmeda, Inc.. 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 14, 2017. Regulation: 8.

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