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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 K082521
Device Name EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
Original Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 pekeris st.
po box 527
rehovot,  IS 76100
Original Contact alex gonorovsky
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN  
Date Received09/02/2008
Decision Date 01/16/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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