510(k) K890913

SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT by Shimadzu Precision Instruments, Inc. — Product Code IYO

K890913 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT". The FDA issued a decision of Substantially Equivalent on September 6, 1989. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.