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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name alternate controller enabled insulin infusion pump
510(k) Number K213134
Device Name Accu-Chek Solo micropump system with interoperable technology
Applicant
Roche Diabetes Care GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Applicant Contact Wolfgang Handel
Correspondent
Roche Diabetes Care GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Correspondent Contact Wolfgang Handel
Regulation Number880.5730
Classification Product Code
QFG  
Subsequent Product Code
KZH  
Date Received09/27/2021
Decision Date 08/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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