Zio AT® device (A100A1001)

Zio AT® device (A100A1001) is an FDA 510(k)-cleared medical device (K240177) manufactured by iRhythm Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2024. Regulation: 8.