
Datex-Ohmeda
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DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE is an FDA 510(k)-cleared medical device (K021279) 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 July 18, 2002. Regulation: 8.