BLADDERMANAGER PCI 5000 MODEL 1002

BLADDERMANAGER PCI 5000 MODEL 1002 is an FDA 510(k)-cleared medical device (K982568) 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 January 24, 1999. Regulation: 8.