510(k) K955840

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 by Diagnostic Ultrasound Corp. — Product Code IYO

K955840 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000". The FDA issued a decision of Substantially Equivalent on May 24, 1996. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.