510(k) K935024

ESI-5000 by Elscint, Inc. — Product Code IYN

K935024 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "ESI-5000". The FDA issued a decision of Substantially Equivalent on June 12, 1996. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Elscint, Inc. has at least 10 other 510(k) clearances on record.