FDA 510(k) K234055, DEKA Loop, by Deka Research and Development
FDA 510(k) K234055, DEKA Loop, by Deka Research and Development
Device Classification Name: Interoperable Automated Glycemic Controller
510(k) Number: K234055
Device Name: DEKA Loop
Applicant: Deka Research and Development
Regulation Number: 862.1356
Classification Product Code: QJI
Date Received: 2023-12-22
Decision Date: 2024-03-13
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 8,399
Fully redacted pages: 7,573
Content pages: 826
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