510(k) Report

Devices descending from K960817

18 later devices reach HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134051Transonic Elsa SystemTransonic Systems, Inc.20150—
+1K030456Vasc-AlertVasc-Alert, LLC20035—
+1K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp.19986—
+1K980906Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc.199810—
+2K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc.20121—
+2K080116Transonic Costatus Cardiac Output SystemTransonic Systems, Inc.200821
+2K060008Aquadex Flexflow SystemChf Solutions, Inc.20064—
+2K042566Vasc-AlertVasc-Alert, Inc.20044—
+2K022963Transonic Syringe Warmer, Model Syr-1000Transonic Systems, Inc.20020—
+2K992227Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp.19990—
+3K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC20103—
+3K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc.20063—
+4K130579Physoft AmsPhysicians Software Systems, LLC20132—
+4K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc.20072—
+5K232283PhySoftAMS®Physician Software Systems, LLC20230—
+5K180410Dosis SAMDosis, Inc.20190—
+5K071854Aquadex Flexflow SystemChf Solutions, Inc.20071—
+6K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.20200Class I