AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM

AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM is an FDA 510(k)-cleared medical device (K896356) manufactured by Esaote Biomedica Spa. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 1990. Regulation: 8.