510(k) Report

Devices descending from K013032

5 later devices reach Physiolog, Series 95000 through their predicates, nearest generation first.

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