ULTRAMARK 7 ULTRASOUND SYSTEM

ULTRAMARK 7 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K896543) manufactured by Advanced Technology Laboratories, 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 February 14, 1990. Regulation: 8.