sam X1 Long Duration Ultrasound Device

sam X1 Long Duration Ultrasound Device is an FDA 510(k)-cleared medical device (K211513) 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 August 17, 2021. Regulation: 8.