FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology, by Roche Diabetes Care GmbH
FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology, by Roche Diabetes Care GmbH
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
Regulation Number: 880.573
Classification Product Code: QFG
Date Received: 2021-09-27
Decision Date: 2023-08-10
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 1,500
Fully redacted pages: 1,319
Content pages: 181
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