
Draeger Medical Systems, Inc.
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INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL is an FDA 510(k)-cleared medical device (K070566) manufactured by Draeger Medical Systems, 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 June 3, 2007. Regulation: 8.