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Codonics, Inc.
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CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P is an FDA 510(k)-cleared medical device (K101439) manufactured by Codonics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2011. Regulation: 8.