SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR is an FDA 510(k)-cleared medical device (K920333) manufactured by Koven and Assoc., 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 January 21, 1993. Regulation: 8.