510(k) Report

Devices descending from K161738

2 later devices reach FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—
+1K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation20180—