510(k) K023143

ECHO SOUNDER, ES-102EX by Koven Technology, Inc. — Product Code KNG

K023143 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "ECHO SOUNDER, ES-102EX". The FDA issued a decision of Substantially Equivalent on December 19, 2002. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Koven Technology, Inc. has at least 10 other 510(k) clearances on record.