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Teratech Corp.
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PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS is an FDA 510(k)-cleared medical device (K110482) manufactured by Teratech Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2011. Regulation: 8.