510(k) Report

Devices descending from K071348

7 later devices reach Ems-XL Cardiac Electrophysiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV201451
+1K091165Horizon XvuMennen Medical, Ltd.20090—
+2K161245EP-TRACER SystemCardio Tek, BV201641
+3K183266EP-TRACER SystemSchwarzer Cardiotek GmbH201931
+4K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.20260—
+4K220306ECGenius SystemCath Vision Aps20221—
+5K223787ECGenius SystemCath Vision Aps20230—