510(k) K120882

SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE by Bard Access Systems, Inc. — Product Code IYO

K120882 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on May 30, 2012. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.