FDA 510(k) K234027, embecta Insulin Delivery System, by Embecta Medical I, LLC
FDA 510(k) K234027, embecta Insulin Delivery System, by Embecta Medical I, LLC
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
510(k) Number: K234027
Device Name: embecta Insulin Delivery System
Applicant: Embecta Medical I, LLC
Regulation Number: 880.5730
Classification Product Code: QFG
Date Received: 12/20/2023
Decision Date: 08/30/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 18,310
Fully redacted pages: 15,651
Content pages: 2,659
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