
Koven Technology, Inc.
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SMARTDOP 45 VASCULAR DOPPLER is an FDA 510(k)-cleared medical device (K050601) 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 April 14, 2005. Regulation: 8.