sam 2.0 Long Ultrasound Device

sam 2.0 Long Ultrasound Device is an FDA 510(k)-cleared medical device (K223019) 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 June 22, 2023. Regulation: 8.