510(k) Report

Devices descending from K062434

14 later devices reach Zero-Click Data Management System, Model 8000-01528 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100937PC Care Blood Glucose Data Management SoftwareI-Sens, Inc.20101—
+1K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix201011—
+2K132821Agamatrix Health ManagerAgamatrix, Inc.20130—
+2K123136Genesis Health Record System, (GHRS)Genesis Health Technologies20130—
+2K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc.20119—
+3K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc.20161—
+3K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc.20144—
+3K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc.20131—
+4K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc.20160—
+4K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.201521
+4K150299Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+4K132148S HealthSamsung Electronics Co., Ltd.20130—
+5K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd.20180—
+5K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.20170—