510(k) Report

Devices descending from K020440

9 later devices reach Newcor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc.20132—
+1K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+2K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+2K150493SensisSiemens Medi Cal Solutions, Inc.2015111
+2K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+3K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+3K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+3K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+3K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—