BLADDERSCAN BVI 9400 ULTRASOUND

BLADDERSCAN BVI 9400 ULTRASOUND is an FDA 510(k)-cleared medical device (K071217) manufactured by Verathon Incorporated. 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 16, 2007. Regulation: 8.