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FDA 510(k) Application Details - K213134
Device Classification Name
More FDA Info for this Device
510(K) Number
K213134
Device Name
Accu-Chek Solo micropump system with interoperable technology
Applicant
Roche Diabetes Care GmbH
Sandhofer Strasse 116
Mannheim 68305 DE
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Contact
Wolfgang Handel
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Regulation Number
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Classification Product Code
QFG
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More FDA Info for this Product Code
Date Received
09/27/2021
Decision Date
08/10/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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