510(k) Report

Devices descending from K170231

1 later device reach iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd.20190—