510(k) Report

Devices descending from K980906

10 later devices reach Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc.20121—
+1K080116Transonic Costatus Cardiac Output SystemTransonic Systems, Inc.200821
+1K030456Vasc-AlertVasc-Alert, LLC20035—
+1K022963Transonic Syringe Warmer, Model Syr-1000Transonic Systems, Inc.20020—
+2K134051Transonic Elsa SystemTransonic Systems, Inc.20150—
+2K042566Vasc-AlertVasc-Alert, Inc.20044—
+3K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC20103—
+4K130579Physoft AmsPhysicians Software Systems, LLC20132—
+5K232283PhySoftAMS®Physician Software Systems, LLC20230—
+5K180410Dosis SAMDosis, Inc.20190—