
GE Healthcare
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DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE is an FDA 510(k)-cleared medical device (K071889) manufactured by GE Healthcare. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2008. Regulation: 8.