510(k) Report

Devices descending from K951739

2 later devices reach Pump/Blood Chemistry Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.20171—
+2K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation20200—