FDA 510(k) K203689, Tidepool Loop, by Tidepool Project
FDA 510(k) K203689, Tidepool Loop, by Tidepool Project
Device Classification Name: Interoperable Automated Glycemic Controller
510(k) Number: K203689
Device Name: Tidepool Loop
Applicant: Tidepool Project
Regulation Number: 862.1356
Classification Product Code: QJI
Date Received: 12/17/2020
Decision Date: 01/23/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 5,000
Fully redacted pages: 2,167
Content pages: 2,833
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