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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 K103396
Device Name COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
Applicant
I-Sens, Inc.
100 Garden City Plz.,
Site 412b
Garden City,  NY  11530
Applicant Contact STANLEY R GOODMAN
Correspondent
I-Sens, Inc.
100 Garden City Plz.,
Site 412b
Garden City,  NY  11530
Correspondent Contact STANLEY R GOODMAN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received11/19/2010
Decision Date 09/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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