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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 K150910
Device Name ACCU-CHEK Connect Diabetes Management App
Applicant
ROCHE DIABETES CARE INC.
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact CHUNHONG TAO
Correspondent
ROCHE DIABETES CARE INC.
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact CHUNHONG TAO
Regulation Number868.1890
Classification Product Code
NDC  
Subsequent Product Codes
JQP   LFR   LZG  
Date Received04/03/2015
Decision Date 06/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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