510(k) Report

Devices descending from K110017

10 later devices reach AG-608N Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemAndon Health Co, Ltd.20170—
+1K132180Ideal Life Gluco-Manager Blood Glucose Monitoring SystemIdeal Life, Inc.20140—
+1K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd.20133—
+1K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd.20127—
+2K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.20162—
+2K133790Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd.20142—
+3K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20171—
+3K153286iHealth Align Gluco-Monitoring systemAndon Health Co, Ltd.20160—
+3K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20150—
+4K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd.20190—