
Zargis Medical Corp.
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ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 is an FDA 510(k)-cleared medical device (K060197) manufactured by Zargis Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2006. Regulation: 8.