510(k) K944485

4000 AU ULTRASOUND IMAGING SYSTEM by Biosound, Inc. — Product Code IYO

K944485 is an FDA 510(k) premarket notification submitted by Biosound, Inc. for the device "4000 AU ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 1995. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Biosound, Inc. has at least 10 other 510(k) clearances on record.