510(k) Report

Devices descending from K131497

3 later devices reach Mckesson Cardiology Hemo through their predicates, nearest generation first.

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