sam 2.0 Long Duration Ultrasound System

sam 2.0 Long Duration Ultrasound System is an FDA 510(k)-cleared medical device (K191568) manufactured by ZetrOZ Systems, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2020. Regulation: 8.