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GE Healthcare
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DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 is an FDA 510(k)-cleared medical device (K070421) 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 March 12, 2007. Regulation: 8.