510(k) K093713

ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM by Civco Medical Instruments — Product Code ITX

K093713 is an FDA 510(k) premarket notification submitted by Civco Medical Instruments for the device "ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 19, 2010. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570.