510(k) K153201

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System by Sd Biosensor — Product Code NBW

K153201 is an FDA 510(k) premarket notification submitted by Sd Biosensor for the device "SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on June 24, 2016. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Sd Biosensor has at least 5 other 510(k) clearances on record.