510(k) K982444

7250 ULTRASOUND IMAGING SYSTEM by Biosound Esaote, Inc. — Product Code IYO

K982444 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "7250 ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1998. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.