510(k) K031504

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX by Koven Technology, Inc. — Product Code KNG

K031504 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX". The FDA issued a decision of Substantially Equivalent on July 18, 2003. 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.