510(k) Report

Devices descending from K902716

21 later devices reach PE Electrophysiology Lab System (Peep) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990058QMS Mapping System,Model 2000Cathdata, Inc.19990—
+1K971570Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp.199719—
+2K993414Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc.200018—
+3K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd.20077—
+3K020440NewcorSiemens Medical Systems, Inc.2002910
+4K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV201451
+4K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc.20132—
+4K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+4K091165Horizon XvuMennen Medical, Ltd.20090—
+5K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+5K161245EP-TRACER SystemCardio Tek, BV201641
+5K150493SensisSiemens Medi Cal Solutions, Inc.2015111
+5K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+6K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+6K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+6K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+6K183266EP-TRACER SystemSchwarzer Cardiotek GmbH201931
+6K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+7K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.20260—
+7K220306ECGenius SystemCath Vision Aps20221—
+8K223787ECGenius SystemCath Vision Aps20230—