HUMANSCAN M5S-D ULTRASOUND TRANSDUCER

HUMANSCAN M5S-D ULTRASOUND TRANSDUCER is an FDA 510(k)-cleared medical device (K083824) manufactured by Humanscan Company, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2009. Regulation: 8.