510(k) Report

Devices descending from K093262

11 later devices reach AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110017AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd.201210—
+2K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemAndon Health Co, Ltd.20170—
+2K132180Ideal Life Gluco-Manager Blood Glucose Monitoring SystemIdeal Life, Inc.20140—
+2K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd.20133—
+2K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd.20127—
+3K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.20162—
+3K133790Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd.20142—
+4K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20171—
+4K153286iHealth Align Gluco-Monitoring systemAndon Health Co, Ltd.20160—
+4K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20150—
+5K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd.20190—