510(k) K082456

VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 by Verathon Incorporated — Product Code IYO

K082456 is an FDA 510(k) premarket notification submitted by Verathon Incorporated for the device "VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600". The FDA issued a decision of Substantially Equivalent on Dec 1, 2008. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Verathon Incorporated has 4 other 510(k) clearances on record.