510(k) Report

Devices descending from K131230

4 later devices reach Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.201521
+1K150299Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+2K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd.20180—
+2K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.20170—