510(k) K170614

CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System by I-Sens, Inc. — Product Code NBW

K170614 is an FDA 510(k) premarket notification submitted by I-Sens, Inc. for the device "CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on October 19, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. I-Sens, Inc. has at least 10 other 510(k) clearances on record.