Tidepool Loop— 510(k) K203689

Name: FDA 510(k) clearance K203689
Creator: U.S. Food and Drug Administration
Published: 2023-01-23

Substantially Equivalent

Tidepool Project

FDA 510(k) clearance K203689 for Tidepool Loop, Substantially Equivalent on 2023-01-23. Applicant: Tidepool Project. Device class: 2.

Clearance details

Applicant: Tidepool Project
Product code: Code QJI
Device class: Class 2
Regulation: 21 CFR 862.1356
Advisory panel: Clinical Chemistry
Date received: 2020-12-17
Decision date: 2023-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.