510(k) Report

Devices descending from K993414

18 later devices reach Prucka Engineering Inc. Cardiolab EP System,Version 4.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd.20077—
+1K020440NewcorSiemens Medical Systems, Inc.2002910
+2K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV201451
+2K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc.20132—
+2K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+2K091165Horizon XvuMennen Medical, Ltd.20090—
+3K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+3K161245EP-TRACER SystemCardio Tek, BV201641
+3K150493SensisSiemens Medi Cal Solutions, Inc.2015111
+3K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+4K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+4K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+4K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+4K183266EP-TRACER SystemSchwarzer Cardiotek GmbH201931
+4K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+5K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.20260—
+5K220306ECGenius SystemCath Vision Aps20221—
+6K223787ECGenius SystemCath Vision Aps20230—