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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, drug dose
510(k) Number K141929
FOIA Releasable 510(k) K141929
Device Name ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
Applicant
ROCHE DIAGNOSTICS CORPORATION
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact CHUNHONG(EMMA) TAO
Correspondent
ROCHE DIAGNOSTICS CORPORATION
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact CHUNHONG(EMMA) TAO
Regulation Number868.1890
Classification Product Code
NDC  
Subsequent Product Codes
JQP   LFR   LZG  
Date Received07/16/2014
Decision Date 03/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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