BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 is an FDA 510(k)-cleared medical device (K955840) manufactured by Diagnostic Ultrasound Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 1996. Regulation: 8.