510(k) Report

Devices descending from K153278

2 later devices reach Wireless Smart Gluco-Monitoring System through their predicates, nearest generation first.

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