BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM

BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K895645) manufactured by Biosound, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 1990. Regulation: 8.