510(k) Report

Devices descending from K101571

5 later devices reach Xper Information Management and Flex Cardio Physiomonitoring Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+1K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+2K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+2K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+2K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—