
Dynacardia, Inc.
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QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) is an FDA 510(k)-cleared medical device (K093172) manufactured by Dynacardia, 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 January 19, 2010. Regulation: 8.