510(k) Report

Devices descending from K161245

4 later devices reach EP-TRACER System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183266EP-TRACER SystemSchwarzer Cardiotek GmbH201931
+2K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.20260—
+2K220306ECGenius SystemCath Vision Aps20221—
+3K223787ECGenius SystemCath Vision Aps20230—