FDA 510(k) K223213, Tandem Mobi Insulin Pump with Interoperable Technology, by Tandem Diabetes Care, Inc.
FDA 510(k) K223213, Tandem Mobi Insulin Pump with Interoperable Technology, by Tandem Diabetes Care, Inc.
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
510(k) Number: K223213
Device Name: Tandem Mobi Insulin Pump with Interoperable Technology
Applicant: Tandem Diabetes Care, Inc.
Regulation Number: 880.573
Classification Product Code: QFG
Date Received: 2022-10-17
Decision Date: 2023-07-10
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 1,500
Fully redacted pages: 1,430
Content pages: 70
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