510(k) Report

Devices descending from K122161

4 later devices reach SJM Confirm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+2K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+3K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+3K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—