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Datex-Ohmeda
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CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) is an FDA 510(k)-cleared medical device (K000168) manufactured by Datex-Ohmeda. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 2000. Regulation: 8.