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Koven Technology, Inc.
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ECHO SOUNDER EX-101EX 8 MHZ is an FDA 510(k)-cleared medical device (K031931) manufactured by Koven Technology, 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 February 12, 2004. Regulation: 8.