510(k) K090214

VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND by Verathon Incorporated — Product Code IYO

K090214 is an FDA 510(k) premarket notification submitted by Verathon Incorporated for the device "VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND". The FDA issued a decision of Substantially Equivalent on Mar 13, 2009. 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.