510(k) Report

Devices descending from K103021

3 later devices reach Element Plus Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132406Elementv Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+1K113670Element Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+2K133045Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—