510(k) Report

Devices descending from K123935

3 later devices reach Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.20162—
+2K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20171—
+3K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd.20190—