myMerlin(TM) Mobile Application Model APP1001

myMerlin(TM) Mobile Application Model APP1001 is an FDA 510(k)-cleared medical device (K173232) manufactured by 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 November 1, 2017. Regulation: 8.