
Datex-Ohmeda
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DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 is an FDA 510(k)-cleared medical device (K013246) 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 December 10, 2001. Regulation: 8.