510(k) K132288

CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER by I-Sens, Inc. — Product Code NBW

K132288 is an FDA 510(k) premarket notification submitted by I-Sens, Inc. for the device "CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER". The FDA issued a decision of Substantially Equivalent on November 22, 2013. 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.