SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR

SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR is an FDA 510(k)-cleared medical device (K942613) 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 December 22, 1994. Regulation: 8.