Cleared Special

CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

K132288 · I-Sens, Inc. · Chemistry
Nov 2013
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K132288 is an FDA 510(k) clearance for the CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by I-Sens, Inc. (Seoul, Korea, KR). The FDA issued a Cleared decision on November 22, 2013, 122 days after receiving the submission on July 23, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K132288 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2013
Decision Date November 22, 2013
Days to Decision 122 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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