510(k) Report

Devices descending from K950436

6 later devices reach Witt Biomedical Series IV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013032Physiolog, Series 95000Camtronics, Ltd.20025—
+2K050561WindsurferMedcon, Ltd.200544
+3K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+4K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+4K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+4K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—