MYOPACH ULTRASONIC PACHOMETER

MYOPACH ULTRASONIC PACHOMETER is an FDA 510(k)-cleared medical device (K844112) manufactured by Myocure, 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 January 15, 1986. Regulation: 8.