myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is an FDA 510(k)-cleared medical device (K193310) manufactured by Abbott (St. Jude Medical). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 16, 2020. Regulation: 8.