KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K896437) manufactured by Kontron Instruments, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1990. Regulation: 8.