
GE Healthcare Finland Oy
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GE DATEX-OHMEDA S/5 ADU CARESTATION is an FDA 510(k)-cleared medical device (K090892) manufactured by GE Healthcare Finland Oy. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2009. Regulation: 8.