510(k) Report

Devices descending from K130181

6 later devices reach Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose…Infopia Co, Ltd.20160—
+1K132966Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…Infopia Co, Ltd.20134—
+2K203562Finetest Lite Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd.20210—
+2K182286Oh'Care Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd.20181—
+2K150274GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose…Infopia Co, Ltd.20150—
+3K201396Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd.20200—