EKOS ultrasound EVD Device, EVD Control Unit

EKOS ultrasound EVD Device, EVD Control Unit is an FDA 510(k)-cleared medical device (K172035) manufactured by Btg International, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2018. Regulation: 8.