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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 Rd.
Indianapolis,  IN  46250
Applicant Contact CHUNHONG TAO
Correspondent
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianapolis,  IN  46250
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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