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Datex-Ohmeda, Inc.
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S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 is an FDA 510(k)-cleared medical device (K002478) manufactured by Datex-Ohmeda, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2000. Regulation: 8.