510(k) Report

Devices descending from K161299

2 later devices reach BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+1K182992BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp.20180—