510(k) K100402

SITE-RITE VISION ULTRASOUND SYSTEM by Bard Access Systems, Inc. — Product Code IYN

K100402 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "SITE-RITE VISION ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.