ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX is an FDA 510(k)-cleared medical device (K031504) manufactured by Koven Technology, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2003. Regulation: 8.