BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY

BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY is an FDA 510(k)-cleared medical device (K954397) 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 March 28, 1996. Regulation: 8.