510(k) Report

Devices descending from K101597

11 later devices reach Wavesense Diabetes Manager Model Version 1.3.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132821Agamatrix Health ManagerAgamatrix, Inc.20130—
+1K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc.20119—
+2K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc.20161—
+2K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc.20144—
+2K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc.20131—
+3K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc.20160—
+3K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.201521
+3K150299Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+3K132148S HealthSamsung Electronics Co., Ltd.20130—
+4K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd.20180—
+4K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.20170—