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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(K) Number K121133
Model GM505UAA
Device Name CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
I-SENS, INC.
465-6 wolgye-dong, nowon-gu
seoul, 
Contact hyun joon oh
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received04/13/2012
Decision Date 07/10/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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