BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000

BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 is an FDA 510(k)-cleared medical device (K963585) 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 September 30, 1996. Regulation: 8.