510(k) K980468

AU5 ULTRASOUND IMAGING SYSTEM by Biosound Esaote, Inc. — Product Code IYN

K980468 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "AU5 ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 26, 1998. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.